Effects of Amlodipine in the Management of Chronic Heart Failure

NCT ID: NCT00151619

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-10

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Amlodipine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Eric Bellissant, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

Service de Réanimation Médicale - Hôpital Raymond Poincaré

Garches, , France

Service de Réadaptation Cardio-Vasculaire - Clinique St Yves

Rennes, , France

Countries

France

References

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. doi: 10.1016/0735-1097(93)90478-j.

Reference Type: BACKGROUND

PMID: 8376684 (View on PubMed)

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. doi: 10.1056/NEJM199108013250502.

Reference Type: BACKGROUND

PMID: 2057035 (View on PubMed)

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. doi: 10.1056/NEJM199610103351504.

Reference Type: BACKGROUND

PMID: 8813041 (View on PubMed)

Other Identifiers

LOC-H/95-02

Identifier Type: -

Identifier Source: secondary_id

CIC0203/005

Identifier Type: -

Identifier Source: secondary_id

AFSSAPS 960723

Identifier Type: -

Identifier Source: org_study_id