© 2005 European Society of Cardiology
How much responsibility should heart failure nurses take?
a Heart Failure Liaison Service Level 4 CRI, Western Infirmary, Dumbarton Road, Glasgow G11 6NT, UK
b Department of Cardiology, Western Infirmary Dumbarton Road, Glasgow G11 6NT, UK
* Corresponding author. E-mail address: j.mcmurray{at}bio.gla.ac.uk
| Abstract |
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This article examines the emerging role of the heart failure nurse and the responsibilities and educational and training requirements surrounding such a role. There may be variations in the role and its responsibilities in different health care settings. However the principles are similar and include: history taking, carrying out clinical assessment and making appropriate decisions about patient management within the context of practice. An example of this is nurse supervision of adjusting and titration of medication in a clinic setting or in the patient's own home. A major challenge to this role is defining the limitations and scope of practice.
Patients with chronic heart failure (CHF) are generally a frail, elderly population, and often have significant other co-morbidities. They can be on multiple medications and are frequently prescribed sub-optimal doses of evidence-based medication [1] [McMurray JJV, Failure to practise evidence-based medicine: why do physicians not treat patients with heart failure with angiotensin-converting enzyme inhibitors? Eur. Heart J. 19 (1998) L15–L21]. Many patients are not managed by specialists [2] [McMurray J, McDonagh T, Morrison CE, Dargie HJ. Eur. Heart J. 14 (1993) 1158–1162], thus creating a huge potential for improved management.
Key Words: Heart failure nurse Chronic heart failure Co-morbidities
Received May 18, 2004; Revised November 9, 2004; Accepted January 10, 2005
| 1. Introduction |
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Heart failure is well recognised as a major and growing public health problem around the world. It is not only a common condition, it is also costly, disabling and deadly [3]. Despite the development and introduction of more effective pharmacological agents in the treatment of this complex syndrome, heart failure continues to be associated with frequent hospital admission, poor quality of life, premature mortality and a high financial burden. At present most healthcare systems are overstretched and unable to meet the complex needs of these patients.
Several studies have suggested that readmissions might have been avoided in 40–59% of patients if discharge had been more carefully planned, if rehabilitation had been more adequate, if potential non-compliance problems with medications had been identified, and if patients had been instructed to seek medical attention when symptoms first occurred [4–7].
Innovative ways to manage this patient group are required to both reduce cost and improve delivery of care. A number of randomised trials of nurse-led interventions in heart failure management carried out in Europe, North America and Australia, have shown that specialist heart failure nurses have the potential to make a substantial impact on the over-all burden of heart failure in limiting costly admissions, in addition to improving quality of life on an individual basis [8–11]. Indeed a recent meta-analysis has found that, collectively, these trials show that this type of intervention may even reduce mortality [12]. A number of key features are common to these intervention programmes and are outlined in Table 1.
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| 2. History of the nurse practitioner |
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The role of nurse practitioner (NP) emerged in the United States (US) around 1965 [13] and the United Kingdom (UK) introduced a nurse practitioner role in the 1980's. In some countries, the role developed in response to a shortage of medical practitioners particularly in remote areas. Initially these practitioners were mainly centred in rural areas in primary care [13,14]. Since then the role has developed and expanded and there are now nurse practitioners providing healthcare in primary and acute settings, for example, in the US and the UK nurse practitioners have been introduced into emergency departments [15,16] and specialty medical and surgical areas [17,18]. In the Netherlands, the nurse practitioner role was initially introduced in the acute health care setting but is now also developing in primary care. Other countries throughout Europe are also implementing this role, using the title of nurse practitioner.
In Australia in 1990, it was acknowledged that many nurses in rural and remote areas had been functioning as nurse practitioners for years. The constraints these nurses faced included; legal barriers against prescribing, referring and ordering tests [19]. This resulted in a task force being set up and, in 1998, after 6 years of research and debate, resulted in Australia's first legislative recognition of nurse practitioners through amendments to the New South Wales Nurses Act of 1991. This legislation allows select nurses in New South Wales to practice independently and deems it an offence to practice as a nurse practitioner without accreditation. The accredited nurse practitioner has limited prescribing rights, the ability to order tests and make referrals within specified clinical guidelines [20].
| 3. The emerging role of the heart failure nurse |
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The number of heart failure nurses has rapidly increased over the past decade and the role is well established in many countries. There are however many variations in the scope of the role and in the form of education and practice preparation. Heart failure nurses work in both primary and secondary care settings and many are involved in clinical research trials.
In the US, the development of dedicated heart failure clinics managed by advanced practice nurses (APN) has emerged over the last decade as a result of recommendations by various health care advisory bodies, [21,22] because of a range of potential benefits, including lowering the cost of care for CHF by reducing in-patient admissions. Following this, specialty clinics have developed at a rapid rate throughout the US. The APN generally requires a master's degree with five years clinical practice in areas consistent with the area of specialisation; there are, however, nurses working as a NP/APN who do not have a master's degree [23].
In Sweden the management of patients with CHF is mainly in out-patient heart failure clinics. The first heart failure clinic was set up in 1990 and currently there are heart failure clinics in more than two thirds of Sweden's hospitals and according to the National Board of Health and Welfare in Sweden, there are 1056 primary care centres in Sweden and approximately 50 have HF clinics though this number is increasing. Many of these clinics are run by heart failure nurses and some of the tasks they perform in the clinics are not within the usual nursing responsibilities, for example, changes to medication including titration. These responsibilities are based on the nurses' competencies and there is close co-operation between the physician and heart failure nurse [24]. The nurses are known as heart failure nurses, however this is not an official title as it has not been established by the National Board of Health and Welfare. The title nurse practitioner— or advanced nurse practitioner— does not exist. At present there is no master's programme in heart failure nursing, but there is one master's programme in cardiovascular nursing and several universities have accredited courses for heart failure nurses. Most heart failure nurses have taken such a course.
In the Netherlands, the first heart failure clinic started in 1994 and currently 60% of hospitals and several home care organisations have started heart failure clinics. The heart failure nurse still comes under the role of specialist nurse although some nurse practitioners are now training and specialising in the field of heart failure. Most of the nurses have a first nursing degree. Heart failure knowledge is obtained through a basic course of 4–5 days, training in the work place supported by the cardiologist, symposia and study days. In some clinics, nurses have an active role in administration and titration of medical therapy. In other clinics, nurses only change medication after consultation with the cardiologist. At present there is no standardised official training for heart failure nurses [25].
The UK appears to be moving towards a more home-based approach, following evidence from a randomised controlled trial implemented in Glasgow, Scotland [10]. This trial looked at the impact of nurse-led home-based intervention on patients with CHF following hospital discharge. The results from the trial showed a reduction of 50% in readmissions related to CHF and as a result of the positive outcome, a number of health authorities and the British Heart Foundation have funded posts for heart failure nurses to develop services based on this model. Generally most heart failure nurses in the UK are experienced nurses from a cardiology/research background. The majority have a first degree, and many have or are working towards master's level although at present there is no master's programme in heart failure.
In the UK, the first formal and academically accredited educational programme to prepare nurses and other allied health care professionals to manage patients with CHF was developed in 2002. This was in conjunction with a university, the British Heart Foundation and the British Society for Heart Failure and 175 nurses have completed or are in the process of completing the programme which is delivered in a flexible and part time mode. The programme can be used as part of a degree award. For existing graduates, attaining a pass on the programme plus an additional module, for example clinical assessment or a module which permits the student and their employer to agree a relevant work based learning contract, will result in attaining a Post Graduate Certificate in Chronic Heart Failure—. The assessment of participants on this course includes: an examination, an objective structured clinical examination (OSCE), a case study and an assessment of competency by their workplace clinical mentor. Due to a high demand, and to allow easier access, a franchise has recently been agreed to roll out the programme to a second UK university. The programme is as outlined in Table 2. It is recommended that nurses involved in the management of patients with CHF undertake this programme in order to prepare them for this role.
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It is clear from this summary that the education and training of nurses for a role in managing patients with CHF is highly variable. This is probably, in part, because the role itself is so variable between countries and even between centres within countries. A further problem is that the development of the heart failure nurse was not a centrally planned and organised one in any country and the development of educational and training programmes often came after individual nurses had developed expertise in managing heart failure on a local hospital by hospital basis. Finally, an additional difficulty in trying to compare educational programmes across countries is that it is not even clear that the same terms mean the same thing in different countries (e.g. a "Master's degree"). As yet, there has been little research into which approach to nurse education and training is best.
| 4. Role definition |
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Role definition has the potential to influence the responsibility the heart failure nurse is able to take. Confusion over the titles of clinical posts in nursing is well documented [26,27]. The status of the heart failure nurse is influenced by the role definition of advanced nurse practitioner/nurse practitioner. Due to the lack of a global definition of advanced nursing practice and the variations in the role of nurse practitioner, it is difficult to determine whether heart failure nurses fit into this role. Most heart failure nurses are working in an extended, autonomous nursing role.
At present in the UK, as in most other European countries, there is no definition of advanced practice in nursing. There are a number of role titles that do not necessarily reflect the nurse's qualifications, for example, a nurse may hold the title of nurse practitioner but not hold any additional or recognised qualification for the role. Currently many role titles for nurses are not recognised by the UK Nursing and Midwifery Council and at international level there is little differentiation between advanced practice nurse and the role title of nurse practitioner.
A framework has been developed by the National Council for the Professional Development of Nursing and Midwifery in Ireland for the establishment of nurse practitioner posts and this includes a definition and core concepts of the role as well as a pathway to accreditation [28]. Heart failure nurses in Ireland are currently registered as Clinical Nurse Specialists and to obtain Advanced Nurse Practitioner accreditation, they are required to have a Masters Degree.
Creating a global definition of advanced practice nursing appears to be difficult and even in the US the practice activities of nurse practitioners have not been well defined [29]. At both national and international level, there would be advantages in reaching an agreed definition of the nurse practitioner/advanced nurse practitioner/specialist nurse role and would help provide a framework for the regulation of practice and the use of role titles and a framework for the level and scope of theoretical and post-registration education [30].
In the UK, the Department of Health document Agenda for Change— [31] provides further support to the need to reward the actual responsibilities that staff take on rather than the job title they work under.
However, with reduction in junior hospital doctors' hours and the shortfall of doctors in primary care, nurses can be viewed as replacement for doctors without sufficient consideration of how they will fit into, and be accepted, in the healthcare team. These shortages also provide an opportunity for the development and implementation of nurse-led initiatives and developing nursing roles.
Appointing nursing staff to new roles which do not yet have a clear structure, or role responsibilities firmly established and agreed, can lead to the new nurse feeling a lack of control and understanding of what the job entails. A steep learning curve can result in much anxiety [30]. It is important that planned and structured support mechanisms are in place and appropriate personnel identified to provide preceptorship and mentorship for those taking up new roles. It is also important that new roles have a clinical career pathway to enable the nurse to see development opportunities.
| 5. Responsibilities—model of care |
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Autonomy has been described as a situation where nurses are free to exercise judgement on their actions, where they accept responsibility for these actions, and where they can consequently be held accountable for these actions [32]. The level of clinical autonomy offered to a heart failure nurse is likely to be influenced by a number of factors, for example, the employing authority's interpretation of the role, the perceptions of the healthcare team on the scope of practice and role boundaries, and the presence or absence of clinical protocols. However not all heart failure nurses are exercising similar levels of clinical autonomy and the responsibilities of the role may vary depending on the model of care, for example, the nurse working in a clinic setting will usually have easy access to another health care professional for advice.
Home-based management is an effective model to manage frail, high risk patients, but requires the nurse making a clinical assessment in the patient's home and deciding a management plan with no immediate access to other members of the health care team. The subsequent transfer of information regarding the patient's condition to the general practitioner or hospital physician is based on the nurse's assessment and communication. It is therefore vital that the heart failure nurse employed in such a role is competent, aware of the limitations and boundaries of the role and his/her knowledge, has easy access to clinical advice and has received appropriate training and education.
Boundaries of responsibility are particularly important if members of the team are working between primary and secondary care and when there is not a shared clinic for easy communication and shared planning of care. A shared clinic at a dedicated time each week is an ideal way for the multidisciplinary team to communicate on more difficult cases and is a model used successfully in cancer care and increasingly being adopted in many heart failure centres throughout Europe.
Protocols are a very useful tool for heart failure nurses to increase their scope of practice and the majority of heart failure nurses work within agreed protocols which are written to ensure a high level and standard of care reflecting best practice—. Protocols are especially important if the nurse has the authority to initiate and adjust medication.
Examples of an extended heart failure nurse role using medical therapy guidelines are briefly outlined in Table 3.
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Assessing a patient with heart failure involves the same principles as assessing any other patient, those of history taking, clinical examination and ordering appropriate investigations. The formal clinical assessment of patients has traditionally been undertaken by doctors, following a systematic approach, while nursing assessment has traditionally been based on a more comprehensive history, the monitoring of objective observations and a more gradual gathering of first-hand information. With the increasing role of the specialist nurse throughout healthcare, a marrying of these two approaches is required [33].
| 6. Qualifications, competence, training and education |
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There is a lack of published literature addressing the structure and content of educational programmes for nurse practitioners. The structure, level and content of training and education for advanced practitioner roles varies enormously. The role of the heart failure nurse requires advanced clinical skills and the development of clinical skills is an essential part of preparation for this role. This raises many questions, for example, should chest auscultation and measuring jugular venous pressure (JVP) be part of this role? If the nurse is not undertaking this as part of their role are they under-performing? If heart failure nurses are required to be competent in these skills how should they be trained and certified as competent?
To ensure the nurse is confident and competent in clinical assessment skills requires both theoretical and formalised follow-up teaching sessions with an appropriate mentor in a clinical setting.
When developing educational programmes, it is important that appropriate clinical mentors are available, that the curricula are reality-based and that there is close collaboration between employers and those providing the education. Acquiring advanced clinical skills has led to a number of creative learning and teaching approaches, for example, the use of objective structured clinical examination (OSCE). Even more innovative approaches including e-learning and distance learning could be considered although these would create challenges for practical teaching of clinical examination.
An example of content for a heart failure training programme is outlined in Table 2.
| 7. Supplementary prescribing |
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In the UK, supplementary prescribing has evolved as a result of government directives [34] to extend prescribing responsibilities to other health professionals to work more flexibly in organising and delivering services around the needs of patients. This is a voluntary prescribing partnership between an independent prescriber (a doctor or a dentist) and a supplementary prescriber (registered nurse, registered midwife or pharmacist), to implement an agreed patient specific clinical management plan with the patient's agreement. A clinical management plan must always be written with shared access to the patient's record.
Supplementary prescribing is intended to improve patient care by providing patients with a more rapid and efficient access to medicines, to effectively utilise the skills of trained nurses and pharmacists and also has the potential to reduce the workload of the general practitioner/primary care physician. Time initially spent developing a clinical management plan should be time saved when the patient returns for review. This new role will potentially permit appropriately accredited heart failure nurses to not only adjust and optimise medical therapy but also initiate medical therapy.
| 8. Accountability |
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All registered nurses are personally accountable for their practice. In many instances the heart failure nurse takes on tasks and responsibilities that have previously been the remit of medical staff and many are increasingly working without direct medical support. Newly appointed nurses may feel vulnerable in this expanded role. A study from the US [35] highlighted that new nurse practitioners can often feel insecure, isolated and under stress and this could have a detrimental effect on their ability to take responsibility.
In the UK, the Royal College of Nursing has indicated that the principle of vicarious liability determines that it is generally the employer who is legally liable if things go wrong, and NPs are no more vulnerable to claims of negligence than other nurses [36].
| 9. Conclusion |
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The ability for heart failure nurses to make an impact on the management of patients with heart failure is considerable. The level of autonomy that the nurse is able to function at depends on a number of variables including: access to appropriate and accredited educational programmes, supervised practical training, support to continue education and professional development, clearly defined roles and boundaries of responsibility agreed by both management and support from medical colleagues and audit of practice and standards.
At present, there is no formal agreement on what the content of such educational and training programmes should be. Indeed, the roles and responsibilities of heart failure nurses vary considerably between different European countries, reflecting, among other things, the culture of the health care system and the part played by nurses more generally in it. Consequently, the education and training needs of nurses will also vary according to the health care system they work in and the roles and responsibilities permitted within that system.
All of the factors mentioned above are also the ones that determine how much responsibility nurses caring for patients with heart failure should and can take. A nurse with a sound theoretical knowledge, intensive practical training, good medical support, working within a system that culturally and legally supports nurse autonomy and subject to audit and quality control should be able to take responsibility for diagnosis (history taking, examination and investigation), treatment (initiating and titrating treatments), monitoring (blood chemistry and haematology, clinical status), patient education and problem solving (dealing with common medical crises, e.g. decompensation, gout, psychological and social problems, if only to recognise these and seek the appropriate professional assistance).
Within the constraints of this short paper, it has been impossible to explore educational programmes for heart failure nurses throughout Europe in any great depth and our focus has been largely on education in the UK which the reader may be able to contextualise for his or her own country. However, we believe that education that is awarded at a level of academic accreditation and quality assured through a university is a sound starting point, though research into the optimum means of educating and training heart failure nurses is needed. There are other important issues to consider. The foremost of these is whether a common European standard for the content of an educational programme could be agreed. We have put forward some suggestions as to what might be considered as core content (Tables 1–3![]()
). Agreement on the practical training (as opposed to core knowledge) of nurses might be more difficult, given the diversity of health care systems, cultural acceptance of the role of the nurse and legal frameworks across Europe and elsewhere. As a first step, a Europe-wide consultation process is needed to assess the demand for a common core curriculum and the potential advantages and disadvantages of a common set of European standards. A key point for discussion will be the transferability of an accredited, competence-based, educational model. This is a priority area warranting further exploration.
It has to be acknowledged that this role will continue to evolve as a result of changes in service delivery and treatment strategies, and has potential to impact on future educational requirements. Pertinent areas for development include clinical assessment, palliative care and nurse prescribing.
Examples of Medical Therapy Guidelines to enable heart failure nurses to adjust, titrate and monitor medical therapy. These guidelines have been used successfully since July 2000 in a nurse-led home-based heart failure service.
1. LOOP DIURETICS
On reviewing the patient ask "has the diuretic been given in a sufficient daily dose to achieve dry weight" (the goal of treatment)? In other words is the patient oedema free and is the jugular venous pressure (JVP) normal?
Problems
Timing—the patient must understand that their diuretic dose(s) need not be fixed. Postponement of their morning dose to ensure for example, a comfortable shopping trip or travel is perfectly acceptable. Unfortunately, however, taking a loop diuretic (e.g., frusemide or bumetanide) after 1600–1800 h can lead to nocturia
Overtreatment—can cause dizziness, light-headedness, fatigue (or a "washed out" feeling) and uraemia. This can be a particular problem if the patient becomes dehydrated for another reason (diarrhoea, vomiting, hot weather, and poor fluid intake); gout can also occur. Usually the patient will show a significant (i.e.
1 kg) and sustained decrease in weight below dry weight. The patients JVP may not be visible at 45°.
Note: In the elderly, symptoms of dehydration may be relatively non-specific, e.g. confusion, impaired mobility, falls or the development of urinary incontinence.
Dose adjustment
Increasing the diuretic dose—the dose of diuretic should be up-titrated if the patient shows a sustained (>3 day) and significant (> 1 kg) increase in weight above dry weight, especially if this is accompanied by an increase in peripheral oedema, the JVP or the symptom of breathlessness. The patient's diuretic dose should be increased, initially, for three days; the dose increment should be maintained and advice sought from the contact cardiologist if dry weight is not regained by the end of three days of increased therapy. The nurse should only make one incremental change without taking advice.
- If the patient is taking 40 mg of frusemide (bumetanide equivalent=1 mg) once daily the dose should be increased to 80 mg once daily. If the patient is taking 80 mg once daily the dose should be increased to 80 mg once (morning) and 40 mg once (lunchtime) daily. If the patient is taking 80 mg and 40 mg once daily the dose should be increased to 80 mg twice daily. If the patient is taking 80 mg frusemide twice daily or more advice should be sought from the contact cardiologist before increasing the dose of diuretic.
Decreasing the diuretic dose—this should only be done cautiously and the patient should be contacted 48 hours later to assess his/her response to the dose reduction. The dose should only be reduced from the usual maintenance once only if there are signs of volume depletion and hypoperfusion. In other words there should be evidence of significant weight loss from dry weight (
1 kg), a rising blood urea (
5 mmol/L or
25 percent) and/or symptoms of dizziness (e.g. postural hypotension) or feeling "dried out". The dose of diuretic should not be reduced if there is peripheral oedema or if the JVP is elevated to
7 cm from the sternal angle. If the patient has a rising blood urea, falling weight and/or symptoms of dizziness/dehydration but peripheral oedema please seek advice from the contact cardiologist.
- Overall, the dose of diuretic should not be decreased to below 40 mg of frusemide (or equivalent) without discussion with the contact cardiologist. Dose reduction should be carried out in 40 mg of frusemide increments, i.e. the reverse of the up-titration schedule outlined above. If the patient is taking >80 mg bd of frusemide, discuss with the contact cardiologist before changing the dose.
- If the patient is taking 40 mg of frusemide (bumetanide equivalent=1 mg) once daily the dose should be increased to 80 mg once daily. If the patient is taking 80 mg once daily the dose should be increased to 80 mg once (morning) and 40 mg once (lunchtime) daily. If the patient is taking 80 mg and 40 mg once daily the dose should be increased to 80 mg twice daily. If the patient is taking 80 mg frusemide twice daily or more advice should be sought from the contact cardiologist before increasing the dose of diuretic.
2. Thiazide Diuretics and metolazone
These diuretics may be used as an alternative to loop diuretics in patients with less severe heart failure or in addition to loop diuretics in patients with very severe heart failure. Unlike loop diuretics, thiazides and metolazone are long acting and adjustment of the timing of dosing is not advantageous as for loop diuretics. Otherwise the principles of use, monitoring, problems etc are similar. Combination of thiazide/metolazone and loop diuretic must be used with extreme caution and only after careful medical consultation. Close biochemical monitoring of combination therapy is mandatory for the first 4 weeks. If blood chemistry remains stable over this period and thiazide/metolazone therapy is to continue, monthly checks thereafter are sufficient provided there is no change in the dose of diuretic, ACE inhibitor or spironolactone or the addition of any drug or intercurrent illness that might affect renal function. Thiazides/metolazone can also cause hyponatraemia, in addition to the other biochemical problems discussed under loop diuretics. If the serum sodium falls below 131 mmol/L, advice should be sought from the contact cardiologist.
Blood chemistry monitoring
When a patient is referred to the Heart Failure Liaison Nurse Service baseline blood chemistry should be measured (sodium, potassium, urea, creatinine). After any sustained (>1 week) increase of diuretic dose, blood chemistry must be rechecked within 1 week. Increases in urea and creatinine and increases or decreases in potassium are of concern. If the urea increases to
20 mmol/L (or by >10 mmol) and/or creatinine increases to
300 µmol/L (or by >100 µmol/L) immediate advice should be sought from the contact cardiologist (generally, in the absence of signs of salt and water retention, the dose of diuretic should be reduced). If the potassium decreases to 3.5 mmol/L or below, immediate advice should be sought from the contact cardiologist (generally, in the absence of signs of salt and water retention, the dose of diuretics should be reduced; alternatively the dose of ACE inhibitor can be increased or spironolactone added). If the potassium increases to 5.5 mmol/L or above immediate advice should be sought from the contact cardiologist (generally, in the absence of signs of salt and water retention, the dose of diuretic should be reduced, alternatively the dose of ACE inhibitor may need to be reduced or spironolactone or non-steroidal anti inflammatory drugs (NSAIDs) may need to be discontinued).
3. ACE inhibitors
Before starting an ACE inhibitor, please consult the patient's GP. Captopril, enalapril, ramipril and lisinopril are the preferred ACE inhibitors and all patients should, if at all possible, be prescribed an ACE inhibitor. The target doses are captopril 50–100 mg tds, enalapril 10–20 mg bd, ramipril 10 mg once daily or lisinopril 30 mg once daily. Every effort should be made to achieve the target dose (or as high as tolerated). Target doses are taken from the SIGN guideline page 21 [37]. The dose of ACE inhibitor should be increased in the absence of severe asymptomatic hypotension (SBP <90 mm Hg), symptomatic hypotension or significant renal impairment (i.e. creatinine
200 µmol/L and or urea
15 mmol/L); if any of these contraindications are present in a patient receiving a below target dose of ACE inhibitor seek advice from the contact cardiologist. In the absence of a contraindication increase, the dose of enalapril, ramipril, lisinopril in 2.5 mg increments and the dose of captopril in 12.5 mg increments, e.g. enalapril 2.5 mg bd, 5 mg bd, 10 mg bd, etc. There should be at least 1 week between dose increments. Before the next dose, increment contraindications should be checked for and, if present, advice should be sought from the contact cardiologist. In other words blood pressure and blood chemistry must be checked within 1 week of a dose increment and before the next dose increment. Detailed advice on the initiation and titration of ACE inhibitors is taken from the SIGN guideline page 20 [37].
Problems
Cough, hypoperfusion (cerebral and renal) and angio-oedema are the major adverse effects associated with ACE inhibitor therapy. If a patient has a genuinely troublesome cough clearly related to ACE inhibitor, an angiotensin II receptor antagonist should be substituted; please seek advice from the contact cardiologist. Cerebral hypoperfusion presents as dizziness, blackouts, light-headedness, etc. Very often this can be resolved by reduction in concomitant medication, i.e. diuretics and, especially nitrates, beta-blockers and calcium channel blockers. If this problem arises, please seek advice from contact cardiologist. It is very important to note that patients taking an ACE inhibitor may have a low blood pressure and no symptoms (asymptomatic hypotension). This finding does not necessitate any action unless there is renal hypoperfusion.
Renal hypoperfusion leads to an increase in urea, creatinine and, often potassium. Small increases in urea, creatinine and potassium are common and acceptable consequences of using an ACE inhibitor. If potassium rises to >6.0 mmol/L, the ACE inhibitor must be stopped immediately, at least temporarily, and advice should be sought from the contact cardiologist. If the potassium rises to between 5.5 mmol/L and 5.9 mmols/L, recheck within 24 hours. If after one check, the potassium level remains 5.5 mmol/L–5.9 mmol/L, discuss with contact cardiologist. If the urea increases to
20 mmol/L (or by >10 mmol/L) and/or creatinine to
300 µmol/L (or by >100 µmol/L), the ACE inhibitor should also be stopped immediately. Very often deteriorating renal function is due to over diuresis/dehydration (e.g. due to diarrhoea/vomiting) or other concomitant medication (especially NSAIDs, potassium sparing diuretics). Advice should be sought from the contact cardiologist with respect to adjustment or discontinuation of these concomitant treatments. Less serious increases, i.e. urea 5–10 mmol/L or creatinine 50–100 µmol/L should be monitored very closely blood chemistry should be checked every second day and advice from the contact cardiologist should be sought. Small changes in urea (<5 mmol/L) and creatinine (<50 µmol/L) can be ignored provided these changes are stable, i.e. show no progression between two blood tests at least 2 weeks apart.
4. SPIRONOLACTONE
This treatment should only be started after discussion with the contact cardiologist and the patient's GP.
Eligible patients
Patients who remain symptomatic on less than ordinary activity (i.e. in NYHA Class III or IV CHF), despite treatment with a diuretic, ACE inhibitor and, where indicated, a beta-blocker should be considered for treatment with spironolactone (based on the RALES trial). Patients with persisting signs of sodium and water retention (i.e. peripheral oedema) may be particularly suitable for this treatment.
Contraindications and cautions:
- Serum creatinine>200 µmol/L—discuss with contact cardiologist
- Serum urea>11.2 µmol/L—discuss with contact cardiologist
- Serum potassium>4.5 mmol/L—discuss with contact cardiologist
- Concomitant treatment with potassium supplements (e.g. "Slow K") or a potassium sparing diuretic (e.g. amiloride or triamterene). Watch out for combination tablets containing these drugs, e.g. co-amilofruse, Frumil, Frusene. Potassium supplements and potassium sparing diuretics should be discontinued for 2 weeks before giving spironolactone. Combination preparations should be substituted with the appropriate potassium losing diuretic (e.g. frusemide should be substituted for Frumil, Co-amilofruse and Frusene) for 2 weeks before giving spironolactone.
Use of spironolactone-initiation:
- Check baseline blood chemistry (see contraindications/cautions).
- Initiate spironolactone 25 mg once daily (a lower dose may be used where there is concern—see cautions above).
- Recheck blood chemistry after ONE WEEK, TWO WEEKS and FOUR WEEKS of treatment.
- DISCONTINUE treatment with spironolactone and seek advice from the contact cardiologist should any of the following occur at any time:
- creatinine increases to
250 mmol/L or by
25% from baseline (e.g. from 80 to 100 mmol/L
- urea increases to
18 mmol/L or by
50% from baseline, e.g. from 8 to 12 mmol/L
- potassium increases to
5.5 mmol/L
- the patient develops diarrhoea and / or vomiting (or any other cause of sodium and water loss)
Further monitoring of the patient receiving spironolactone
- Further checks of blood chemistry should be made every 4 weeks for 3 months, then every 3 months for 1 year and every 6 months thereafter.
- The patient may become sodium and water depleted and hypovolaemic on spironolactone, necessitating a reduction in the dose of potassium losing diuretic (e.g. frusemide) or discontinuation of spironolactone. This can be expected if
- the patient complains of postural dizziness/light-headedness
- the patient's blood pressure falls excessively and in a sustained way
- the patient exhibits a significant and sustained weight loss (e.g.
1 kg, sustained over
1 week)
- the patient has had some intercurrent illness causing sodium and water depletion (e.g. diarrhoea and vomiting—IF THIS OCCURS STOP SPIRONOLACTONE IMMEDIATELY), has not been drinking fluids or has been in a hot climate, perspiring excessively.
Blood chemistry should be measured immediately if any of the above occur.
You should discuss the patient's clinical status and these blood chemistry results with his/her GP.
5. BETA-BLOCKERS
The contact cardiologist must be contacted before a beta-blocker is started. Beta-blockers must be used with extreme caution, started at a very low dose and up-titrated slowly over a period of weeks. A detailed protocol for the use of beta-blockers is outlined below.
The evidence
The increased sympathetic nervous system activity found in chronic heart failure (CHF) has detrimental long-term effects. Higher plasma noradrenaline (norepinephrine) concentrations are associated with worse survival.
Four large studies have shown that certain beta-blockers reduce mortality (by about one third) and hospital admissions (by about twenty percent) when added to full conventional heart failure therapy, including ACE inhibitor treatment. These studies are the pooled analysis of the US carvedilol trials (N Engl J Med 1996; 334: 1349–55), the second Cardiac Insufficiency Bisoprolol Study (CIBIS II) [Lancet 1999; 353: 9–13], the Metoprolol CR/XL Randomised Intervention Trial in congestive Heart Failure (MERIT-HF) [Lancet 1999; 353: 2001–07] and COPERNICUS [N Eng J Med 2001; 344: 1651–1658].
Patients who benefit from beta-blocker therapy
- A confirmed diagnosis of CHF due to left ventricular systolic dysfunction demonstrated by echocardiography, radionuclide ventriculography or x-ray contrast ventriculo-graphy.
- In NYHA Class II–IV (see below); class IV patients must be reviewed by a cardiologist before a beta-blocker is started.
- Already receiving standard therapy, i.e. diuretic, ACE inhibitor and, optionally, digoxin
- Clinically stable, i.e.:
No adjustment in dose of treatment in past 2 weeks.
No admission to hospital with heart failure in the past 1 month. Patients who do not fulfil these criteria should be reviewed by a cardiologist if beta-blocker treatment is considered.
Heart rate
55 beats per minute and systolic blood pressure
90 mmHg.
No contraindication to beta-blockade, e.g. asthma, heart block, sick sinus syndrome (consult data sheet).
- In NYHA Class II–IV (see below); class IV patients must be reviewed by a cardiologist before a beta-blocker is started.
New York Heart Association Classification
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Managing adverse effects during dose titration
Adverse events during the initiation and up-titration of beta-blockers in heart failure are not uncommon and patients will often experience temporary deterioration of their heart failure symptoms. This is minimised by careful patient selection, use of a small initial dose of beta-blocker and slow and cautious dose up-titration. Usually initial problems can be overcome by adjustment of the dose of concomitant medications and the majority of appropriate patients can be readily established on beta-blocker therapy. Generally, beta-blocker therapy should not be stopped suddenly, though this may be necessary if the patient develops a significant bradycardia or worsening of symptoms (including symptomatic hypotension).
It is helpful to advise patients that a beta-blocker is prescribed primarily with the objective of maintaining stability and preventing progression of heart failure in the longer term. No immediate symptomatic improvement is expected and, initially, there may be some symptom worsening before improvement occurs.
Worsening heart failure—seek advice from the contact cardiologist
Patients may become more breathless and/or oedematous (or gain weight). Do not further up-titrate the dose of beta-blocker. Usually this can be corrected by increasing the dose of diuretic (this may only be necessary on a temporary basis). Normally the patient should improve within 2–3 days. If the patient does not improve within one week consider also decreasing, or stopping, the dose of beta-blocker. Wait 4 weeks before attempting further dose up-titration or re-initiation of beta-blocker therapy.
Symptomatic hypotension—seek advice from the contact cardiologist
Consider over-diuresis and whether reduction in the dose of diuretic may improve matters.
Consider discontinuing other hypotensive drugs of no definite value in heart failure, e.g. nitrates, calcium channel blockers, alpha adrenoceptor blockers. Consider temporary decrease in dose of ACE inhibitor. If unresolved, decrease dose of, or stop, beta-blocker. Wait 4 weeks before attempting further dose up-titration or reinitiation of beta-blocker therapy and check with the contact cardiologist. If the systolic blood pressure falls to below 90 mm Hg blood chemistry should be checked. Advice should be sought if the changes detailed under diuretics and ACE inhibitors occur (usually the dose of beta-blocker should be reduced).
Excessive bradycardia—seek advice from the contact cardiologist
If the heart rate falls to <55 beats per minute reduce to the previous dose level, e.g. from 10 mg to 5 mg of bisoprolol (if very symptomatic consider stopping treatment immediately). Review within 1 week and reduce dose further if heart rate still <55/min. Review medication and consider reducing dose of or stopping other drugs that can slow sinoatrial and atrioventricular conduction, e.g. digoxin, diltiazem and amiodarone.
If heart rate falls to <45 beats per minute stop beta-blocker and arrange 12 lead ECG. Referral to a cardiologist is advised. This is because such a low heart rate may indicate that beta-blocker therapy has precipitated second or third degree atrioventricular block ("heart block") or sick sinus syndrome.
HOW TO USE BETA-BLOCKERS IN CHF1
The following guidance reflects the current summaries of product characteristics (as of July 2001)
- observe indications and contraindications (previous page)
- treatment must only be initiated "under the supervision of a hospital physician" (carvedilol) or "a physician experienced in the management of heart failure" (bisoprolol)
- therapy must be initiated in the hospital setting at the lowest dose (see below) and up-titrated slowly (see below)—the minimum interval between dose increases should be 2 weeks
- before each dose, up-titration patients must be reviewed by a health care professional experienced in the management of heart failure for adverse effects and signs of worsening heart failure
- patients must be advised of possible adverse effects and to seek assistance (according to local arrangements), should these occur
- treatment must only be initiated "under the supervision of a hospital physician" (carvedilol) or "a physician experienced in the management of heart failure" (bisoprolol)
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1Metoprolol CR/XL, used in MERIT-HF, is not available in the UK.
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