Effects of Amlodipine in the Management of Chronic Heart Failure - Full Text View

Sponsor:	Rennes University Hospital
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00151619

Purpose

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.

Condition	Intervention	Phase
Chronic Heart Failure	Drug: Amlodipine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Heart Failure

Drug Information available for: Amlodipine Amlodipine besylate

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

Humeral blood flow

Secondary Outcome 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.

Estimated Enrollment:	24
Study Start Date:	February 1999

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151619

Locations

France
Service de Réanimation Médicale - Hôpital Raymond Poincaré
Garches, France, 92380
Service de Réadaptation Cardio-Vasculaire - Clinique St Yves
Rennes, France, 35044

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator:

Eric Bellissant, MD, PhD

CHU Rennes

More Information

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.

ClinicalTrials.gov Identifier:	NCT00151619 History of Changes
Other Study ID Numbers:	AFSSAPS 960723, LOC-H/95-02, CIC0203/005
Study First Received:	September 8, 2005
Last Updated:	December 30, 2005
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Rennes University Hospital:

Calcium channel blockers
Heart failure
Hemodynamics

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Amlodipine
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on February 12, 2012