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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Amlodipine

Primary Measures

• Humeral blood flow

Secondary Measures

• 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Rennes University Hospital

Overall Clinical Trial Officials and Contacts

Eric Bellissant, MD, PhD Principal Investigator CHU Rennes  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151619

Study ID Number: AFSSAPS 960723

ClinicalTrials.gov Identifier: NCT00151619

Health Authority: France: Afssaps - French Health Products Safety Agency