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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sanofi
Ministry of Health, France
Sorin Group
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00736294
First received: August 14, 2008
Last updated: July 23, 2014
Last verified: July 2014

August 14, 2008
July 23, 2014
July 2008
March 2016   (final data collection date for primary outcome measure)
At least one relevant symptomatic or asymptomatic atrial fibrillation event [ Time Frame: From D1 to M12 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Secondary effects of the treatment [ Time Frame: From D1 to M12 ] [ Designated as safety issue: Yes ]
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
198
March 2016
March 2016   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00736294
0608066, 2006-007032-10
Yes
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
  • Sanofi
  • Ministry of Health, France
  • Sorin Group
Principal Investigator: Antoine DA COSTA, PhD MD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
July 2014

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