Electrophysiological effects of Irbesartan in patients with paroxysmal AFEfectos electrofisiológicos del Irbesartán en sujetos con FA paroxística

Phase 1

• Conditions: Patients with paroxysmal atrial fibrillation

• Registration Number: EUCTR2005-002809-23-ES
• Lead Sponsor: Bristol-Myers Squibb S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-14
• Study Completion: 2007-06-28
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1) Subjects whose signed written informed consent has been obtained
2) Subjects with documented (on at least one ECG at any moment) recurrent paroxysmal atrial fibrillation who have an indication (and are going to be admitted) for catheter ablation techniques for atrial fibrillation.
3) Men and women, ages 18 to 70 years
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) Structural cardiopathy like hypertensive cardiopathy, familiar cardiomyopathy, LVH, valvular disease, CAD, amyloidosis.
2) AF due to a reversible cause
3) History of thromboembolism during the previous year,
4) Previously documented and /or at visit 1 long QTc > 450 msec
5) Recent MI (less than 6 months), recent stroke (less than 6 months), severe HTN , subjects who require ACEi/ARBs .
6) Subjects with significant liver disease and coagulation problems
7) Subjects with inability to follow protocol procedures according to the investigation
8) Subjects with dementia
9) Subjects unable to come back at all follow up visits
10) Subjects with known intolerance to ARBs
11) Subjects treated with ACEI or ARB during the previous 4 weeks are excluded. A two-week wash out period is permitted.
12) Subjects treated with amiodarone during the previous six months will be excluded.
13) Any drug that could modify electrophysiological parameters: Antiarrythmic drugs including digoxine
14) Drugs with effect on QT intervals like:
a) Disopyramide, Dofetilide, Ibutilide, Procainamide, Quinidine, Sotalol, Bepridil. Probucol.
b) Other drugs: Amiodarone, Arsenic trioxide, Cisapride, Calcium-channel blockers: lidoflazine
c) Antiinfective agents: clarithromycin, erythromycin, halofantrine, pentamidine, sparfloxacin
d) Antiemetic agents: domperidone, droperidol
e) Antipsychotic agents: chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, Methadone
15) Prisoners or subjects who are compulsorily detained
16) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary efficacy outcome measure is the AERP. The secondary outcomes measured are: atrial functional refractory period (AFRP), and the time intervals of inter- and intra-atrial conduction.;Main Objective: To assess the effect of Irbesartan on the atrial effective refractory period (AERP).;Secondary Objective: - To assess the effects of Irbesartan on the atrial functional refractory period (AFRP).<br>- To assess the effects of Irbesartan on atrial conduction intervals, in subjects with paroxysmal AF.<br>- To assess the dispersion of refractoriness.<br>