Effects of Amlodipine in the Management of Chronic Heart Failure

Rennes University Hospital

Status and phase

Terminated

Phase 2

Conditions

Chronic Heart Failure

Treatments

Drug: Amlodipine

Study type

Interventional

Funder types

Other

Identifiers

NCT00151619

CIC0203/005

AFSSAPS 960723

LOC-H/95-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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