FindTrial
Sign In

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.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002013-36-ES
Enrollment
Unknown
Registered
2005-05-25
Start date
2004-12-17
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PACIENTES CON FA PERSISTENTE DE LARGA DURACÍON.

Interventions

Trade Name: GOPTEN® Product Name: GOPTEN® Pharmaceutical Form: Capsule, hard INN or Proposed INN: TRANDOLAPRIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Ph

Sponsors

CONCEPCION MORO SERRANO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026