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Effects of Amlodipine in the Management of Chronic Heart Failure

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00151619
First received: September 8, 2005
Last updated: December 30, 2005
Last verified: December 2005
History of Changes
  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 2

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:

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:

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 May 22, 2013