A Phase 2 interventional study of Amlodipine in Chronic Heart Failure, sponsored by Rennes University Hospital. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Rennes University Hospital · Phase 2, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 7 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Humeral blood flow
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.
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital