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Effects of Amlodipine in the Management of Chronic Heart Failure - Article


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Amlodipine and Benazepril

Lotrel 



Clinical Trial: Effects of Amlodipine in the Management of Chronic Heart Failure

This study has been suspended.
Verified by Rennes University Hospital September 2005

Sponsored by: 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

MedlinePlus related topics:  Cardiomyopathy

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Humeral blood flow
Secondary Outcomes: 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.
Expected Total Enrollment:  24

Study start: February 1999

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 above,  Genders Eligible for Study:  Both
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

Location Information


France
      Service de Réadaptation Cardio-Vasculaire - Clinique St Yves, Rennes,  35044,  France

      Service de Réanimation Médicale - Hôpital Raymond Poincaré, Garches,  92380,  France

Study chairs or principal investigators

Eric Bellissant, MD, PhD,  Principal Investigator,  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.

Study ID Numbers:  AFSSAPS 960723; LOC-H/95-02; CIC0203/005
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00151619
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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Page Updated: June 1, 2005
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