Effects of Amlodipine in the Management of Chronic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151619
Recruitment Status : Suspended
First Posted : September 9, 2005
Last Update Posted : January 2, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Amlodipine Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. Humeral blood flow

Secondary Outcome Measures :
  1. Systemic hemodynamics:
  2. - Systolic and diastolic arterial pressures
  3. - Heart rate and cardiac output
  4. - Systolic and diastolic left ventricular diameters
  5. - Ambulatory measure of arterial pressure
  6. - Isovolumic relaxation time, pulmonary venous flow
  7. Regional hemodynamics:
  8. - Carotid, humeral and femoral arterial diameters and flows
  9. - Arterial compliance
  10. - Renal and hepatosplanchnic blood flow
  11. Stress test
  12. Biological variables: ionogram, hormonal and cytokines plasma concentrations
  13. Functional well-being measure on a Visual Analogue Scale.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00151619

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
Principal Investigator: Eric Bellissant, MD, PhD CHU Rennes

Publications: Identifier: NCT00151619     History of Changes
Other Study ID Numbers: AFSSAPS 960723
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: January 2, 2006
Last Verified: December 2005

Keywords provided by Rennes University Hospital:
Calcium channel blockers
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents