© 2008 European Society of Cardiology
Design of the Heart failure Endpoint evaluation of AII-Antagonist Losartan (HEAAL) study in patients intolerant to ACE-inhibitor
a Tufts Medical Center Boston, MA, USA
b National Heart & Lung Institute, Imperial College London UK
c University of Bergen, Stavanger University Hospital Stavanger, Norway
d Department of Cardiology, Medicine Highschool Hannover Hannover, Germany
e Merck & Co Whitehouse Station, NJ, USA
f Université Pierre et Marie Curie-Paris 6, Departement De Cardiologie, Hospital Pitie-Salpetriere Paris, France
g MSD (Europe) Inc Brussels, Belgium
h Córdoba National University, President of Rusculleda Foundation for Clinical Research Cordoba, Argentina
i University of Minnesota, School of Public Health, Division of Biostatistics Minneapolis, MN, USA
j Clinic and Policlinic for Internal Medicine II Cardiology, University Hospital Regensburg Regensburg, Germany
* Corresponding author. Tufts Medical Center, Box 108, Boston, MA 02111, USA. E-mail address: mkonstam{at}tuftsmedicalcenter.org (M.A. Konstam).
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Abstract |
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Background: In patients with heart failure and reduced left ventricular ejection fraction, angiotensin receptor blockers have been found to reduce mortality and morbidity and to prevent or reverse left ventricular remodelling, compared to optimized background treatment. In light of these data, The Heart failure Endpoint evaluation of Angiotensin II Antagonist Losartan (HEAAL) study was developed to determine whether losartan 150 mg is superior to losartan 50 mg (antihypertensive dose) in reducing morbidity and mortality among patients with symptomatic heart failure who are intolerant of angiotensin-converting enzyme (ACE)-inhibitors.
Aims/methods: To compare the effect of high and moderate doses of losartan on the primary endpoint of all-cause mortality and hospitalisation due to heart failure in patients (n=3834) with symptomatic heart failure and an ejection fraction 
40% who are intolerant of ACE-inhibitor treatment.
Results: This paper presents the rationale, trial design, and baseline characteristics of the study population. The study, which completed recruitment on 31 March 2005, is event-driven and is estimated to accrue the target of 1710 adjudicated primary events during the latter half of 2008.
Conclusions: The results of HEAAL should facilitate selection of an optimal dosing regimen for losartan in patients with symptomatic heart failure who are intolerant of ACE-inhibitors.
Key Words: Angiotensin receptor blocker • Losartan • Heart failure • Morbidity • Mortality
Received December 11, 2007; Revised June 17, 2008; Accepted July 3, 2008
1 On behalf of the Executive Committee of HEAAL investigators.
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