NCT00151619

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 1999

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2.6 years

First QC Date

September 8, 2005

Last Update Submit

March 25, 2019

Conditions

Chronic Heart Failure

Keywords

Calcium channel blockersHeart failureHemodynamics

Outcome Measures

Primary Outcomes (1)

  • Humeral blood flow

Secondary Outcomes (13)

  • Systemic hemodynamics:

  • - Systolic and diastolic arterial pressures

  • - Heart rate and cardiac output

  • - Systolic and diastolic left ventricular diameters

  • - Ambulatory measure of arterial pressure

  • +8 more secondary outcomes

Interventions

AmlodipineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de Réanimation Médicale - Hôpital Raymond Poincaré

Garches, 92380, France

Location

Service de Réadaptation Cardio-Vasculaire - Clinique St Yves

Rennes, 35044, France

Location

Related Publications (3)

  • 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.

    PMID: 8376684BACKGROUND

  • 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.

    PMID: 2057035BACKGROUND

  • 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.

    PMID: 8813041BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eric Bellissant, MD, PhD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

February 10, 1999

Primary Completion

September 6, 2001

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

FR(2)