Effects of Amlodipine in the Management of Chronic Heart Failure

Chronic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00151619
• Other study ID #: AFSSAPS 960723
• Secondary ID: LOC-H/95-02CIC02
• Status: Terminated
• Phase: Phase 2
• Start date: February 10, 1999

Study information

• Verified date: March 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. primary completion date: September 6, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Amlodipine

Locations

Country	Name	City	State
France	Service de Réanimation Médicale - Hôpital Raymond Poincaré	Garches
France	Service de Réadaptation Cardio-Vasculaire - Clinique St Yves	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humeral blood flow
Secondary	Systemic hemodynamics:
Secondary	- Systolic and diastolic arterial pressures
Secondary	- Heart rate and cardiac output
Secondary	- Systolic and diastolic left ventricular diameters
Secondary	- Ambulatory measure of arterial pressure
Secondary	- Isovolumic relaxation time, pulmonary venous flow
Secondary	Regional hemodynamics:
Secondary	- Carotid, humeral and femoral arterial diameters and flows
Secondary	- Arterial compliance
Secondary	- Renal and hepatosplanchnic blood flow
Secondary	Stress test
Secondary	Biological variables: ionogram, hormonal and cytokines plasma concentrations
Secondary	Functional well-being measure on a Visual Analogue Scale.