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

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ClinicalTrials.gov Identifier: NCT00736294
Recruitment Status : Terminated (Difficulty to include patients)
First Posted : August 15, 2008
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):

August 14, 2008
August 15, 2008
July 28, 2015
July 2008
March 2015   (Final data collection date for primary outcome measure)
At least one relevant symptomatic or asymptomatic atrial fibrillation event [ Time Frame: From D1 to M12 ]
Same as current
Complete list of historical versions of study NCT00736294 on ClinicalTrials.gov Archive Site
  • All relevant cardiovascular event [ Time Frame: From D1 to M12 ]
  • Secondary effects of the treatment [ Time Frame: From D1 to M12 ]
Same as current
Not Provided
Not Provided
Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter
Prevention of Atrial Fibrillation by the Prescription of Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter

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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Atrial Flutter
  • Drug: Ramipril
    5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
  • Drug: Placebo
    5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
  • Experimental: Ramipril
    Inhibition Conversion Enzyme
    Intervention: Drug: Ramipril
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2015
March 2015   (Final data collection date for primary outcome measure)

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 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2006-007032-10 ( Other Identifier: ANSM )
Not Provided
Not Provided
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
  • Sanofi
  • Ministry of Health, France
  • LivaNova
Principal Investigator: Antoine DA COSTA, PhD MD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP