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| Sponsor: | Centre Hospitalier Universitaire de Saint Etienne |
|---|---|
| Collaborators: |
Sanofi-Aventis Ministry of Health, France Sorin Group |
| Information provided by: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT00736294 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Atrial Flutter |
Drug: Ramipril Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
| Estimated Enrollment: | 390 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Inhibition Conversion Enzyme
|
Drug: Ramipril
5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
|
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Antoine DA COSTA, PhD MD | +33 (0) 4 77 82 83 40 | antoine.dacosta@chu-st-etienne.fr |
| Contact: Juanita TECHER, CRA | +33 (0) 4 77 12 76 55 | juanita.techer@chu-st-etienne.fr |
| France | |
| CHU de Brest | Recruiting |
| Brest, France, 29609 | |
| Principal Investigator: Marjaneh FATEMI, MD | |
| Sub-Investigator: Jacques MANSOURATI, MD PhD | |
| CHU de Clermont-Ferrand | Recruiting |
| Clermont Ferrand, France, 63003 | |
| Principal Investigator: Hassan MANSOUR, MD | |
| Sub-Investigator: Yannick SALUDAS, MD | |
| Sub-Investigator: Jean PONSONNAILLE, MD PhD | |
| CHU de Grenoble | Recruiting |
| Grenoble, France, 38043 | |
| Principal Investigator: Pascal DEFAYE, MD | |
| Sub-Investigator: Peggy JACON, MD | |
| CHU de Montpellier | Recruiting |
| Montpellier, France, 34295 | |
| Principal Investigator: Jean-Luc PASQUIER, MD | |
| Sub-Investigator: Franck RACZKA, MD | |
| CHU de Saint-Etienne | Recruiting |
| Saint-etienne, France, 42 055 | |
| Principal Investigator: Antoine DA COSTA, MD PhD | |
| Sub-Investigator: Cécile ROMEYER-BOUCHARD, MD | |
| CHU de Rennes | Recruiting |
| Rennes, France, 35033 | |
| Principal Investigator: Dominique PAVIN, MD | |
| Sub-Investigator: Philippe MABO, MD PhD | |
| Sub-Investigator: Claude DAUBERT, MD | |
| Sub-Investigator: Aude SOLNON, MD | |
| Sub-Investigator: Christophe LECLERCQ, MD | |
| CHU de Rouen | Recruiting |
| Rouen, France, 76031 | |
| Principal Investigator: Frédéric ANSELME, MD PhD | |
| Sub-Investigator: Arnaud SAVOURE, MD | |
| Sub-Investigator: Anne-Françoise CAILLEUX, MD | |
| Polyclinique des Fleurs | Not yet recruiting |
| Ollioules, France, 83190 | |
| Principal Investigator: Thierry CHALVIDAN, MD | |
| Sub-Investigator: Olivier ROUX, MD | |
| Principal Investigator: | Antoine DA COSTA, PhD MD | CHU de Saint-Etienne |
More Information
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne ( Clément CAILLAUX ) |
| Study ID Numbers: | 0608066, 2006-007032-10 |
| Study First Received: | August 14, 2008 |
| Last Updated: | January 5, 2010 |
| ClinicalTrials.gov Identifier: | NCT00736294 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority |
|
Catheter Ablation, Radiofrequency Angiotensin-Converting Enzyme Inhibitors |
|
Pathologic Processes Heart Diseases Molecular Mechanisms of Pharmacological Action Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors Cardiovascular Diseases |
Atrial Fibrillation Pharmacologic Actions Atrial Flutter Protease Inhibitors Arrhythmias, Cardiac |