Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter

Last updated: July 27, 2015
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Terminated

Phase

3

Condition

Dysrhythmia

Chest Pain

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT00736294
0608066
2006-007032-10
  • Ages > 18
  • All Genders

Study Summary

Atrial Flutter [AFL] is a relatively frequent arrhythmia, considered as benign, but associated with both invalidating symptoms and thromboembolic risk. The objective of the treatment consists to on the one hand the sinus rhythm [SR] restoration and on the other hand the prevention of the long-term recurrence. In this clinical setting, AFL radiofrequency ablation [RFA] became the first line therapy due to its both high effectiveness and safety. The effectiveness of AFL RFA is attenuated by the subsequent risk of atrial fibrillation [AFib] close to 25% at 1 year. This risk of subsequent AFib is related to the common substrate between both arrhythmias.

When AFib occurs, the interest to maintain the SR is still required, even if recent studies did not show a significant difference in term of total mortality between rate or rhythm control strategies [AFFIRM, RACE and PIAF studies]. The studies published underlined the anti-arrhythmic drugs limits in patients with both arrhythmias [AFib and AFL]. After years centered on the mechanisms and the electric treatments of AFib, researchers are nowadays focusing on the study's evaluation of the atrial tissue substrate.

Accordingly, the renin-angiotensin system role was investigated in many works. Indeed, angiotensin II plays a role in the modification of atrial pressure and in the fibers stretching ["stretch"], conditions required for the development of AFib. Angiotensin II is also a factor implied in the tissue fibrosis leading to tissue proliferation and collagen alteration. These mechanisms lead to atria cells conduction disorders and refractory periods modification. Moreover, the enzyme of conversion expression and the angiotensin II receptors deterioration were observed in patients with AFib.

This brings to the concept of AFib treatment while interfering on tissue remodeling by the way of renin-angiotensin system. Drugs such as the angiotensin converting enzyme inhibition [ACEI] may reduce AFib in patients with heart failure. No randomized study so far has compared the ACEI drugs against placebo among high-risk patients of AFib in post AFL RFA area. On the basis of experimental and clinical study, the investigators seek to evaluate the ACEI use in the prevention of AFib in an AFL post RFA ablation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • first atrial flutter, or recurrence of atrial flutter

  • affiliated or a beneficiary of a social security category

  • treated by radiofrequency ablation (< 72 h)

  • having signed the inform consent form

Exclusion

Exclusion Criteria:

  • contra-indication to right catheterism

  • contra-indication to angiotensin converting enzym inhibitors

  • contra-indication to anticoagulation treatment

  • having already a angiotensin converting enzym inhibitor treatment

  • recent (< 3 months) hearth failure with left ventricular ejection fraction < 45%

  • pregnant women or breast-feeding

  • severe renal disease

  • serum potassium > 5 mmol/l

  • requiring a antiarrythmic treatment

Study Design

Total Participants: 198
Study Start date:
July 01, 2008
Estimated Completion Date:
March 31, 2015

Study Description

The main goal of this study is to compare within 12 months, the effectiveness of an ACEI [Ramipril] versus placebo on the prevention of AFib after AFL RFA.

This study is a randomized, prospective, double blind, multicenter study comparing ramipril vs. placebo in 2 parallel groups.

Connect with a study center

  • CHU de Brest

    Brest, 29609
    France

    Site Not Available

  • CHU de Clermont-Ferrand

    Clermont Ferrand, 63003
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble, 38043
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • Polyclinique des Fleurs

    Ollioules, 83190
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35033
    France

    Site Not Available

  • CHU de Rouen

    Rouen, 76031
    France

    Site Not Available

  • CHU de Saint-Etienne

    Saint-etienne, 42 055
    France

    Site Not Available

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