Effects of Amlodipine in the Management of Chronic Heart Failure

Phase 2

Terminated

• Conditions: Chronic Heart Failure

• Registration Number: NCT00151619
• Lead Sponsor: Rennes University Hospital

Brief 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.

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.

Study Timeline

• Study Start: 1999-02-10
• Primary Completion: 2001-09-06
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Humeral blood flow

Secondary Outcome Measures

Name	Time	Method
- Renal and hepatosplanchnic blood flow
Stress test
Systemic hemodynamics:
- Systolic and diastolic arterial pressures
- Isovolumic relaxation time, pulmonary venous flow
- Arterial compliance
- Heart rate and cardiac output
Biological variables: ionogram, hormonal and cytokines plasma concentrations
Functional well-being measure on a Visual Analogue Scale.
- Systolic and diastolic left ventricular diameters
Regional hemodynamics:
- Ambulatory measure of arterial pressure
- Carotid, humeral and femoral arterial diameters and flows

Trial Locations

Locations (2)

Service de Réanimation Médicale - Hôpital Raymond Poincaré; 🇫🇷 Garches, France

Service de Réadaptation Cardio-Vasculaire - Clinique St Yves; 🇫🇷 Rennes, France