Atrial Fibrillation | Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter
Atrial Fibrillation research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Ramipril5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
Drug:Placebo5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
RamiprilInhibition Conversion Enzyme
Start Date: July 2008
Completed Date: March 2015
Phase: Phase 3
Primary Outcome: At least one relevant symptomatic or asymptomatic atrial fibrillation event
Secondary Outcome: All relevant cardiovascular event
Study sponsors, principal investigator, and references
Principal Investigator: Antoine DA COSTA, PhD MD
Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Da Costa A, Thévenin J, Roche F, Romeyer-Bouchard C, Abdellaoui L, Messier M, Denis L, Faure E, Gonthier R, Kruszynski G, Pages JM, Bonijoly S, Lamaison D, Defaye P, Barthélemy JC, Gouttard T, Isaaz K; Loire-Ardèche-Drôme-Isère-Puy-de-Dôme Trial of Atrial Flutter Investigators. Results from the Loire-Ardèche-Drôme-Isère-Puy-de-Dôme (LADIP) trial on atrial flutter, a multicentric prospective randomized study comparing amiodarone and radiofrequency ablation after the first episode of symptomatic atrial flutter. Circulation. 2006 Oct 17;114(16):1676-81. Epub 2006 Oct 9.