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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736294
Recruitment Status : Terminated (Difficulty to include patients)
First Posted : August 15, 2008
Last Update Posted : July 28, 2015
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Drug: Ramipril Drug: Placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevention of Atrial Fibrillation by the Prescription of Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter
Study Start Date : July 2008
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril

Arm Intervention/treatment
Experimental: Ramipril
Inhibition Conversion Enzyme
Drug: Ramipril
5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets

Placebo Comparator: Placebo
Drug: Placebo
5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets

Primary Outcome Measures :
  1. At least one relevant symptomatic or asymptomatic atrial fibrillation event [ Time Frame: From D1 to M12 ]

Secondary Outcome Measures :
  1. All relevant cardiovascular event [ Time Frame: From D1 to M12 ]
  2. Secondary effects of the treatment [ Time Frame: From D1 to M12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00736294

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CHU de Brest
Brest, France, 29609
CHU de Clermont-Ferrand
Clermont Ferrand, France, 63003
CHU de Grenoble
Grenoble, France, 38043
CHU de Montpellier
Montpellier, France, 34295
Polyclinique des Fleurs
Ollioules, France, 83190
CHU de Rennes
Rennes, France, 35033
CHU de Rouen
Rouen, France, 76031
CHU de Saint-Etienne
Saint-etienne, France, 42 055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
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Principal Investigator: Antoine DA COSTA, PhD MD CHU de Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT00736294    
Other Study ID Numbers: 0608066
2006-007032-10 ( Other Identifier: ANSM )
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Catheter Ablation, Radiofrequency
Angiotensin-Converting Enzyme Inhibitors
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents