Atrial Fibrillation
Conditions
Keywords
Patients with Paroxysmal Atrial Fibrillation (PAF)
Brief summary
The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.
Interventions
DRUGIrbesartan
Tablets, Oral, 300 mg, once daily, 30 days.
DRUGPlacebo
Tablets, Oral, 0 mg, once daily, 30 days.
Sponsors
Sanofi
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Recurrent PAF with indication for catheter ablation
Exclusion criteria
* Struct. Cardiopathy * Mitral valve disease * VEF\<40% * Myocardiopathy * LVH * cardiac surgery * AF reversible * QT c\>450 * Recent MI/stroke, severe HTN * Requirement of ACEI/ARBs * Coronary synd., HTA, liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients. | The measures are taken after 31 days of irbesartan treatment |
Secondary
| Measure | Time frame |
|---|---|
| Irbesartan effect on A Function RP | The measures are taken after 31 days of irbesartan treatment |
| Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients | The measures are taken after 31 days of irbesartan treatment |
| Refractoriness dispersion | The measures are taken after 31 days of irbesartan treatment |
Countries
Spain
Outcome results
None listed