Effects of Amlodipine in the Management of Chronic Heart Failure

Study Overview
=================
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.

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.

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

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: Amlodipine


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amlodipine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humeral blood flow |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcium channel blockers, Heart failure, Hemodynamics