© 2003 European Society of Cardiology
The heart failure revascularisation trial (HEART): rationale, design and methodology
a Department of Academic Cardiology, Castle Hill Hospital Cottingham, Kingston upon Hull HU16 5JQ, UK
b Department of Primary Care and General Practice, University of Birmingham Birmingham B15 2TT, UK
c Institute of Cardiovascular Research, Leeds General Infirmary Leeds LS1 3EX, UK
d Department of Cardiothoracic Surgery, The Queen Elizabeth Hospital Birmigham B15 2TH, UK
e MRC Clinical Sciences Centre, Imperial College of Science Technology and Medicine, Hammersmith Hospital London W12 0NN, UK
f Addenbrooke's Centre for Clinical Investigation, Addenbrooke's Hospital Cambridge CB2 2QQ, UK
g Queen's Medical Centre, University Hospital Nottingham NG7 2UH, UK
h Cardiothoracic Surgical Unit, Papworth Hospital Cambridge CB3 8RE, UK
i The Wolverhampton Hospitals NHS Trust, New Cross Hospital Wolverhampton WV10 0QP, UK
j Cardiovascular Magnetic Resonance Unit, Royal Brompton Hosptial London SW3 6NP, UK
k Royal Brompton Hospital London SW3 6NP, UK
l Cardiac Research Department, Northwick Park Hospital Harrow, Middlesex HA1 3UJ, UK
m Department of Cardiology, Royal Devon and Exeter Hospital Exeter EX2 5DW, UK
* Corresponding author. Tel.: +44-1482-624-084; fax: +44-1482-624-085. E-mail address: g.m.porter{at}hull.ac.uk
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Abstract |
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Background: Most patients with heart failure due to left ventricular systolic dysfunction (LVSD) secondary to coronary artery disease (CAD) have evidence of myocardium in jeopardy (reversible ischaemia and/or stunning hibernation). It is not known whether revascularisation in such cases is safe or beneficial.
Aims: To determine whether revascularisation will improve the survival of patients with LVSD and heart failure secondary to CAD and myocardium in jeopardy.
Methods: This is a randomised controlled trial comparing revascularisation or not, in addition to optimal medical therapy with ACE inhibitors, beta-blockers, aldosterone antagonists and an anti-thrombotic agent. Patients must have heart failure requiring treatment with diuretics, a left ventricular ejection fraction <35% and evidence of coronary disease. Myocardial viability and ischaemia are assessed by a broad range of techniques including stress echocardiography and nuclear imaging. All imaging tests are reviewed in core laboratories to ensure uniform reporting. Any conventional revascularisation technique is permitted. The primary outcome measure is all cause mortality. Symptoms, quality of life and health economic issues will also be explored. Assuming an annual mortality of 10% in the control group and allowing for substantial cross-over rates, a study of 800 patients followed for 5 years has 80% power with an alpha of 0.05 (two-sided) to show a 25% reduction in mortality with revascularisation.
Results: At the time of writing 180 patients have been screened for inclusion, 111 have consented to participate and 70 have been randomised. The results of viability testing are awaited in 22 patients. Twenty-six patients had been investigated for myocardial viability and/or by angiography prior to consent, as part of the routine practice in that cardiology department. Of 68 patients who have completed assessment only after consent, 47 (69%) were included. The principal reason for drop-out between consent and randomisation was lack of evidence of myocardial ischaemia or hibernation.
Conclusion: The HEART trial will help to determine whether investigation of myocardial ischaemia and/or viability with a view to revascularisation should become part of the routine care of patients with heart failure due to LVSD and CAD.
Key Words: Heart failure • Revascularisation • Left ventricular systolic dysfunction • HEART study
Received January 27, 2003; Revised April 14, 2003; Accepted April 16, 2003
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