Trial Outcomes & Findings for n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation (NCT NCT01198275)
NCT ID: NCT01198275
Last Updated: 2012-01-20
Results Overview
Sinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.
COMPLETED
PHASE3
199 participants
one year
2012-01-20
Participant Flow
Participant milestones
| Measure |
n-3 PUFAs
1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
|
Placebo
1.0 g placebo gelatine capsules(olive oil)twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
99
|
|
Overall Study
COMPLETED
|
94
|
94
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
n-3 PUFAs
1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
|
Placebo
1.0 g placebo gelatine capsules(olive oil)twice daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
spontaneous return to sinus rhythm
|
4
|
2
|
Baseline Characteristics
n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
n-3 PUFAs
n=100 Participants
1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
|
Placebo
n=99 Participants
1.0 g placebo gelatine capsules(olive oil)twice daily
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70 years
STANDARD_DEVIATION 6 • n=5 Participants
|
69 years
STANDARD_DEVIATION 9 • n=7 Participants
|
69.6 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearSinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.
Outcome measures
| Measure |
n-3 PUFAs
n=100 Participants
1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
|
Placebo
n=99 Participants
1.0 g placebo gelatine capsules(olive oil)twice daily
|
|---|---|---|
|
Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)
|
61 partecipants
|
34 partecipants
|
SECONDARY outcome
Timeframe: 1, 3 and 6 monthsThe mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.
Outcome measures
Outcome data not reported
Adverse Events
n-3 PUFAs
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Savina Nodari
Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place