Trial Outcomes & Findings for Evaluating the Effectiveness of Fish Oil Supplements at Reducing the Recurrence of Atrial Fibrillation (NCT NCT00552084)

NCT ID: NCT00552084

Last Updated: 2014-12-03

Results Overview

Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 190 participants
• Primary outcome timeframe: Measured at Week 24 or exit
• Results posted on: 2014-12-03

Participant Flow

Participants were recruited at 4 medical centers in Nashville Tennessee, and at the Marsh field Clinic in Madison, Wisconsin. Between December 2007 and December 2012, 241 patients were enrolled and 190 (178 at Vanderbilt, 12 at other sites) were randomized to fish oil (126) or placebo (64). Of 190 enrolled, 173 (91%) completed the study.

Patients were >= 21 years old with a history of at least 2 occurrences of atrial fibrillation or atrial flutter, and in sinus rhythm at randomization. Randomization was performed according to a computer-generated block scheme according to anti-arrhythmic therapy: 1. no therapy, 2. amiodarone, 3. class 1 anti-arrhythmic drugs, 4.sotalol/dofetilide.

Participant milestones

Measure	Fish Oil 4 grams fish oil daily for 24 weeks Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks.	Placebo corn oil taken daily for 24 weeks Placebo: Placebo supplements will be taken daily for 24 weeks.
Overall Study STARTED	126	64
Overall Study COMPLETED	118	55
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Measure	Fish Oil 4 grams fish oil daily for 24 weeks Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks.	Placebo corn oil taken daily for 24 weeks Placebo: Placebo supplements will be taken daily for 24 weeks.
Overall Study Adverse Event	2	3
Overall Study Withdrawal by Subject	4	5
Overall Study Protocol Violation	1	0
Overall Study change in anti-arrythmic drug	1	1

Baseline Characteristics

Evaluating the Effectiveness of Fish Oil Supplements at Reducing the Recurrence of Atrial Fibrillation

Baseline characteristics by cohort

Measure	Fish Oil n=126 Participants 4 grams fish oil daily for 24 weeks Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks.	Placebo n=64 Participants corn oil taken daily for 24 weeks Placebo: Placebo supplements will be taken daily for 24 weeks.	Total n=190 Participants Total of all reporting groups
Age, Continuous	61.9 years n=5 Participants	61.5 years n=7 Participants	61.7 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=5 Participants	38 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	64 Participants n=5 Participants	26 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	22 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	42 Participants n=7 Participants	109 Participants n=5 Participants
Region of Enrollment United States	126 participants n=5 Participants	64 participants n=7 Participants	190 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Week 24 or exit

Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.

Outcome measures

Measure	Fish Oil n=126 Participants 4 grams fish oil daily for 24 weeks Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks.	Placebo n=64 Participants corn oil taken daily for 24 weeks Placebo: Placebo supplements will be taken daily for 24 weeks.
Documented Recurrence of Atrial Fibrillation/Atrial Flutter	59 percentage of participants	47 percentage of participants

Adverse Events

Fish Oil

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fish Oil n=126 participants at risk 4 grams fish oil daily for 24 weeks Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks.	Placebo n=64 participants at risk corn oil taken daily for 24 weeks Placebo: Placebo supplements will be taken daily for 24 weeks.
Musculoskeletal and connective tissue disorders pseudogout	0.79% 1/126 • Number of events 1 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.	0.00% 0/64 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.
General disorders non-cardiac chest pain	0.79% 1/126 • Number of events 1 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.	0.00% 0/64 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.
Cardiac disorders acute coronary syndrome	0.00% 0/126 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.	1.6% 1/64 • Number of events 1 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.
Cardiac disorders bradycardia	0.00% 0/126 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.	1.6% 1/64 • Number of events 1 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.
Cardiac disorders rapid atrial fibrillation	0.00% 0/126 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.	1.6% 1/64 • Number of events 1 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.

Other adverse events

Measure	Fish Oil n=126 participants at risk 4 grams fish oil daily for 24 weeks Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks.	Placebo n=64 participants at risk corn oil taken daily for 24 weeks Placebo: Placebo supplements will be taken daily for 24 weeks.
Blood and lymphatic system disorders Low INR	13.5% 17/126 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.	3.1% 2/64 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	8.7% 11/126 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.	12.5% 8/64 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.
Gastrointestinal disorders Diarrhea	4.8% 6/126 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.	1.6% 1/64 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.
Gastrointestinal disorders Nausea	4.8% 6/126 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.	3.1% 2/64 • Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.

Additional Information

Dr. C Michael Stein

Vanderbilt University Medical Center

Phone: 615-936-3420

Email: mike.stein@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place