Effects of Amlodipine in the Management of Chronic Heart Failure
Information source: Rennes University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Heart Failure
Intervention: Amlodipine (Drug)
Phase: Phase 2
Status: Suspended
Sponsored by: Rennes University Hospital Official(s) and/or principal investigator(s):
Eric Bellissant, MD, PhD, Principal Investigator, Affiliation: CHU Rennes
Summary
Patients with congestive heart failure are usually treated with a combination of an ACE
inhibitor (or an AT1 blocking agent), a diuretic and a beta-blocker. However, some patients
remain symptomatic despite an optimal treatment with these drugs. In patients who also have
coronary heart disease, nitrates or some calcium-channel blockers could help to relieve
symptoms. Therefore, the aim of our study is to evaluate the additional benefit induced by a
second generation calcium-channel blocker, amlodipine, in patients with chronic heart failure
who remain symptomatic despite an optimal treatment.
Clinical Details
Official title: Regional and Systemic Hemodynamic Effects of a Long-Term Administration of Amlodipine in Patients With Chronic Heart Failure Treated With a Combination of Enalapril, Furosemide and Digoxin
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Humeral blood flow
Secondary outcome: Systemic hemodynamics:- Systolic and diastolic arterial pressures - Heart rate and cardiac output - Systolic and diastolic left ventricular diameters - Ambulatory measure of arterial pressure - Isovolumic relaxation time, pulmonary venous flow Regional hemodynamics: - Carotid, humeral and femoral arterial diameters and flows - Arterial compliance - Renal and hepatosplanchnic blood flow Stress test Biological variables: ionogram, hormonal and cytokines plasma concentrations Functional well-being measure on a Visual Analogue Scale.
Detailed description:
In patients with congestive heart failure, a treatment with ACE inhibitor combined with
digoxin and a diuretic has shown benefits on morbidity and mortality. However, 40% of these
patients have persistant symptoms. The rationale for the use of calcium channel blockers in
patients with chronic heart failure lies in their vasodilating action, antiischemic effect,
ability to reduce left ventricular diastolic dysfunction. The objective of our study is to
evaluate the regional and systemic hemodynamic, hormonal and vascular effects and the
tolerance to stress test of a 3-months treatment with amlodipine. Patients with stable
chronic heart failure (III/IV NYHA) and treated with a combination of enalapril, furosemide
and digoxin will be randomized to receive amlodipine 5 or 10 mg or a placebo for a 3-months
period.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients over 18 years
- Chronic heart failure with New York Heart Association class III or IV.
- Ischemic or dilated cardiopathy known for at least 3 months
- Systolic arterial pressure > 110 mmHg under treatment
- Stroke volume between 20 and 40% under treatment
- Informed written consent
Exclusion Criteria:
- History of allergy to one of the studied pharmaceutical classes
- History of troubles in ventricular rythm (tachycardia, fibrillation) or acute heart
failure
- Chronic renal, hepatic or respiratory failure
- Diabetes
- Valvulopathy
- Myocarditis,constrictive pericarditis
- Life prognosis < 6 months due to a non cardiac pathology
- Absence of woman contraception, pregnancy, breast-feeding
- Treatment with calcium channel blockers or antiarrythmics class IC
- Unstable patient under standardized treatment
- Unable to do a stress test
Locations and Contacts
Service de Réadaptation Cardio-Vasculaire - Clinique St Yves, Rennes 35044, France
Service de Réanimation Médicale - Hôpital Raymond Poincaré, Garches 92380, France
Additional Information
Related publications: Elkayam U, Shotan A, Mehra A, Ostrzega E. Calcium channel blockers in heart failure. J Am Coll Cardiol. 1993 Oct;22(4 Suppl A):139A-144A. Review. Cohn JN, Johnson G, Ziesche S, Cobb F, Francis G, Tristani F, Smith R, Dunkman WB, Loeb H, Wong M, et al. A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of chronic congestive heart failure. N Engl J Med. 1991 Aug 1;325(5):303-10. Packer M, O'Connor CM, Ghali JK, Pressler ML, Carson PE, Belkin RN, Miller AB, Neuberg GW, Frid D, Wertheimer JH, Cropp AB, DeMets DL. Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group. N Engl J Med. 1996 Oct 10;335(15):1107-14.
Starting date: February 1999
Last updated: December 30, 2005
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