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Effects of Amlodipine in the Management of Chronic Heart Failure

Primary Purpose

Chronic Heart Failure

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Amlodipine

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Calcium channel blockers, Heart failure, Hemodynamics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Réanimation Médicale - Hôpital Raymond Poincaré
Service de Réadaptation Cardio-Vasculaire - Clinique St Yves

Outcomes

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.

Full Information

NCT ID

NCT00151619

First Posted

September 8, 2005

Last Updated

March 25, 2019

Sponsor

Rennes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00151619

Brief Title

Effects of Amlodipine in the Management of Chronic Heart Failure

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 Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Terminated

Study Start Date

February 10, 1999 (Actual)

Primary Completion Date

September 6, 2001 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Rennes University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

Keywords

Calcium channel blockers, Heart failure, Hemodynamics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Amlodipine

Primary Outcome Measure Information:

Title

Humeral blood flow

Secondary Outcome Measure Information:

Title

Systemic hemodynamics:

Title

- Systolic and diastolic arterial pressures

Title

- Heart rate and cardiac output

Title

- Systolic and diastolic left ventricular diameters

Title

- Ambulatory measure of arterial pressure

Title

- Isovolumic relaxation time, pulmonary venous flow

Title

Regional hemodynamics:

Title

- Carotid, humeral and femoral arterial diameters and flows

Title

- Arterial compliance

Title

- Renal and hepatosplanchnic blood flow

Title

Stress test

Title

Biological variables: ionogram, hormonal and cytokines plasma concentrations

Title

Functional well-being measure on a Visual Analogue Scale.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Bellissant, MD, PhD

Organizational Affiliation

CHU Rennes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Réanimation Médicale - Hôpital Raymond Poincaré

City

Garches

ZIP/Postal Code

92380

Country

France

Facility Name

Service de Réadaptation Cardio-Vasculaire - Clinique St Yves

City

Rennes

ZIP/Postal Code

35044

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

8376684

Citation

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. doi: 10.1016/0735-1097(93)90478-j.

Results Reference

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PubMed Identifier

2057035

Citation

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. doi: 10.1056/NEJM199108013250502.

Results Reference

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PubMed Identifier

8813041

Citation

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. doi: 10.1056/NEJM199610103351504.

Results Reference

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Effects of Amlodipine in the Management of Chronic Heart Failure

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