Trial Outcomes & Findings for Effects of Fish Oil on Post Ablation Arrhythmias (NCT NCT00791089)

NCT ID: NCT00791089

Last Updated: 2017-09-12

Results Overview

Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias with or without antiarrhythmic drug (AAD) therapy as shown in the two lines

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-09-12

Participant Flow

All of the 12 participants were assigned to an intervention, but none completed all aspects of the study, because of study termination due to funding withdrawal. Still, basic baseline and outcome measure data was available for 11 of the 12, as noted below.

Participant milestones

Measure	Fish Oil, Ablation, Sinus Rhythm Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure. LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF. LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.	Placebo, Ablation, Sinus Rhythm Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo. placebo: Control group will receive placebo before \& after ablation.
Overall Study STARTED	6	6
Overall Study Began Actually Taking Fish Oil or Placeb	6	5
Overall Study Six-month Data Collected	6	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One age for one participant randomized to this arm is unavailable. This participant actually never began placebo.

Baseline characteristics by cohort

Measure	Fish Oil, Ablation n=6 Participants Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure. LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF. LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.	Placebo, Ablation, Sinus Rhythm n=5 Participants Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo. placebo: Control group will receive placebo before \& after ablation.	Total n=11 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants • One age for one participant randomized to this arm is unavailable. This participant actually never began placebo.	48.8 years n=7 Participants • One age for one participant randomized to this arm is unavailable. This participant actually never began placebo.	52.7 years n=5 Participants • One age for one participant randomized to this arm is unavailable. This participant actually never began placebo.
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias with or without antiarrhythmic drug (AAD) therapy as shown in the two lines

Outcome measures

Measure	Fish Oil, Ablation n=6 Participants Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure. LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF. LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.	Placebo, Ablation n=5 Participants Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo. placebo: Control group will receive placebo before \& after ablation.
Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias) FREEDOM FROM ATRIAL ARRHYTHMIAS WITHOUT AAD	1 Participants	2 Participants
Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias) FREEDOM FROM ATRIAL ARRHYTHMIAS WITH AAD	3 Participants	1 Participants

Adverse Events

Fish Oil, Ablation

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo, Ablation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fish Oil, Ablation n=6 participants at risk Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure. LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF. LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.	Placebo, Ablation n=6 participants at risk Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo. placebo: Control group will receive placebo before \& after ablation.
Surgical and medical procedures Cardiac Tamponnade	16.7% 1/6 • 6 months	0.00% 0/6 • 6 months

Other adverse events

Measure	Fish Oil, Ablation n=6 participants at risk Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure. LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF. LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.	Placebo, Ablation n=6 participants at risk Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo. placebo: Control group will receive placebo before \& after ablation.
Psychiatric disorders Anxiety	0.00% 0/6 • 6 months	16.7% 1/6 • 6 months
Surgical and medical procedures Fluid gain	0.00% 0/6 • 6 months	16.7% 1/6 • 6 months
Skin and subcutaneous tissue disorders Spot on Face	0.00% 0/6 • 6 months	16.7% 1/6 • 6 months
Blood and lymphatic system disorders Painful vericose veins	0.00% 0/6 • 6 months	16.7% 1/6 • 6 months
Cardiac disorders Bradycardia	0.00% 0/6 • 6 months	16.7% 1/6 • 6 months
Surgical and medical procedures pneumonitis	16.7% 1/6 • 6 months	0.00% 0/6 • 6 months

Additional Information

Hakan Oral

University of Michigan

Phone: 734 936-6868

Email: oralh@med.umich.edu

Results disclosure agreements

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