Phase 3
N=199
n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01198275 ↗Enrolled (actual)
199
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) — 61; 34 partecipants — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- n-3 PUFAs (Drug); Placebo (Drug); RASS inhibitors and/or RAS blockers (Drug); Amiodarone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) |
61; 34 | < 0.05 sig |
| SECONDARY The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence |
— | — |
Summary
The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm after electrical conversion in patients with persistent Atrial fibrillation (AF).
Eligibility Criteria
Inclusion Criteria
- persistent Atrial Fibrillation (AF) lasting > one month
- history of at least one AF relapse after previous electrical or Pharmacological cardioversion
Exclusion Criteria
- left atrium size > 6 cm
- severe valvulopathy
- myocardial infarction during the previous 6 months
- unstable angina
- NYHA heart failure class IV or hemodynamic instability
- cardiac surgery during the previous 3 months
- significant pulmonary thyroid and hepatic disease
- contraindications to treatment with amiodarone or RASS inhibitors
- chronic renal dysfunction
- QT > 480 msec in the absence of bundle-branch block
- bradycardia < 50 b/min
- diagnosis of paroxysmal AF
- hyperkalemia
- pregnancy
- any disease or other medical treatment that, in the opinion of the investigators, could interfere with the study.
Data sourced from ClinicalTrials.gov (NCT01198275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.