Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter
NCT ID: NCT00736294
Last Updated: 2015-07-28
Study Results
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Basic Information
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TERMINATED
PHASE3
198 participants
INTERVENTIONAL
2008-07-31
2015-03-31
Brief Summary
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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.
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Detailed Description
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This study is a randomized, prospective, double blind, multicenter study comparing ramipril vs. placebo in 2 parallel groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ramipril
Inhibition Conversion Enzyme
Ramipril
5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
Placebo
Placebo
Placebo
5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
Interventions
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Ramipril
5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
Placebo
5 mg/d from D1 to M3 10 mg/d from M3 to M12 Tablets
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Ministry of Health, France
OTHER_GOV
LivaNova
INDUSTRY
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Antoine DA COSTA, PhD MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint-Etienne
Locations
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CHU de Brest
Brest, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CHU de Grenoble
Grenoble, , France
CHU de Montpellier
Montpellier, , France
Polyclinique des Fleurs
Ollioules, , France
CHU de Rennes
Rennes, , France
CHU de Rouen
Rouen, , France
CHU de Saint-Etienne
Saint-Etienne, , France
Countries
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References
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Da Costa A, Thevenin 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, Barthelemy JC, Gouttard T, Isaaz K; Loire-Ardeche-Drome-Isere-Puy-de-Dome Trial of Atrial Flutter Investigators. Results from the Loire-Ardeche-Drome-Isere-Puy-de-Dome (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. doi: 10.1161/CIRCULATIONAHA.106.638395. Epub 2006 Oct 9.
Da Costa A, Romeyer-Bouchard C, Zarqane-Sliman N, Messier M, Samuel B, Kihel A, Faure E, Isaaz K. Impact of first line radiofrequency ablation in patients with lone atrial flutter on the long term risk of subsequent atrial fibrillation. Heart. 2005 Jan;91(1):97-8. doi: 10.1136/hrt.2003.033308. No abstract available.
Madrid AH, Peng J, Zamora J, Marin I, Bernal E, Escobar C, Munos-Tinoco C, Rebollo JM, Moro C. The role of angiotensin receptor blockers and/or angiotensin converting enzyme inhibitors in the prevention of atrial fibrillation in patients with cardiovascular diseases: meta-analysis of randomized controlled clinical trials. Pacing Clin Electrophysiol. 2004 Oct;27(10):1405-10. doi: 10.1111/j.1540-8159.2004.00645.x.
Heart Outcomes Prevention Evaluation Study Investigators; Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi: 10.1056/NEJM200001203420301.
Other Identifiers
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2006-007032-10
Identifier Type: OTHER
Identifier Source: secondary_id
0608066
Identifier Type: -
Identifier Source: org_study_id
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