A PROSPECTIVE DOUBLE BLIND AND RANDOMIZED STUDY ON THE EFFECT OF TRANDOLAPRIL, IN MAINTAINING SINUS RHYTHM IN PATIENTS WITH LONG-LASTING PERSISTENT ATRIAL FIBRILLATION.ESTUDIO PROSPECTIVO, DOBLE CIEGO, RANDOMIZADO, SOBRE EL EFECTO DE TRANDOLAPRIL EN EL MANTENIMIENTO DEL RITMO SINUSAL EN PACIENTES CON FA PERSISTENTE DE LARGA DURACIÓN.

• Conditions: PACIENTES CON FA PERSISTENTE DE LARGA DURACÍON.

• Registration Number: EUCTR2004-002013-36-ES
• Lead Sponsor: CONCEPCION MORO SERRANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.-Persistent Atrial fibrillation episode lasting more than 72 hours.2.- Age over 18 years3.- Anticoagulation with acenocumarol at least 3 weeks before the electrical cardioversion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.- Previous failure of electrical cardioversion.2.- Persistent atrial fibrillation lasting > 1 year.3.- Multiple recurrences after previous electrical cardioversion (> 3).4.- Left atrium > 6 cm.5.- Myocardial infarction during the previous 6 months6.- Cardiac surgery during the previous 30 days7.- Atrial fibrillation associated with an acute reversible condition8.- Thyroid disease, pulmonary or hepatic disease, and or contraindications to treatment with amiodarone.9.- Contraindications of Trandolapril.10.- Pregnancy or fertile female.11.- Psiquiatric disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of our study is to establish the effects of Trandolapril on the acute efficacy of external electrical cardioversion and the recurrences of atrial fibrillation. ;Secondary Objective: 1.- Analyze the effects of Trandolapril on the acute efficacy of electrical cardioversion.2.- Analyze the early recurrences of atrial fibrillation, during the phase of electrical remodeling, between Trandolapril and placebo.3.- The parameters possible related to failure will be analyzed.4.- Evaluate the recurrences during the follow-up of at least 1 year.;Primary end point(s): Efficacy Variable:Time passed before the first recurrences of atrial fibrillation occursSecurity Variable:Asses that the combination of Amiodarona and Trandolapril increases its effectiveness without the increase of the adverse events.