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Chronic Heart FailurePhase 2NCT00151619

Effects of Amlodipine in the Management of Chronic Heart Failure

A Phase 2 study testing Amlodipine in people with Chronic Heart Failure, run by Rennes University Hospital at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
Amlodipine
How many people
7 participants
Where
2 sitesFrance
Study dates
10 Feb 1999to 6 Sep 2001
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Service de Réanimation Médicale - Hôpital Raymond Poincaré

    Garches, 92380

  • Service de Réadaptation Cardio-Vasculaire - Clinique St Yves

    Rennes, 35044

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Amlodipine
Keywords
Calcium channel blockers, Heart failure, Hemodynamics
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Humeral blood flow

Secondary outcomes (13)

  1. Systemic hemodynamics:

  2. - Systolic and diastolic arterial pressures

  3. - Heart rate and cardiac output

  4. - Systolic and diastolic left ventricular diameters

  5. - Ambulatory measure of arterial pressure

  6. - Isovolumic relaxation time, pulmonary venous flow

  7. Regional hemodynamics:

  8. - Carotid, humeral and femoral arterial diameters and flows

  9. - Arterial compliance

  10. - Renal and hepatosplanchnic blood flow

  11. Stress test

  12. Biological variables: ionogram, hormonal and cytokines plasma concentrations

  13. Functional well-being measure on a Visual Analogue Scale.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2005 (estimated)
  2. Study start10 Feb 1999
  3. Primary completion6 Sep 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00151619
Sponsor's protocol ID
AFSSAPS 960723
Other IDs
LOC-H/95-02, CIC0203/005
Status last verified
Mar 2019
First submitted
8 Sep 2005
Last updated
26 Mar 2019
Results posted
No

Publications

  • 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.

    PubMed 8376684

  • 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.

    PubMed 2057035

  • 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.

    PubMed 8813041

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amlodipine in people with Chronic Heart Failure, run by Rennes University Hospital at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Humeral blood flow. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00151619, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.

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