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Effects of Fish Oil on Post Ablation Arrhythmias

This study has been terminated.
(unable to secure funding and long term follow up)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Hakan Oral, University of Michigan
ClinicalTrials.gov Identifier:
NCT00791089
First received: November 13, 2008
Last updated: March 24, 2017
Last verified: March 2017
Results First Received: March 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Drug: LOVAZA Omega 3-acid ethyl esters
Drug: LOVAZA
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
As PI and participants were both blinded till study’s end. All of the 12 participant enrolled began taking their assigned intervention, but none completed because of study termination due to funding withdrawal.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Fish Oil, Ablation, Sinus Rhythm   Placebo, Ablation, Sinus Rhythm
STARTED   6   6 
COMPLETED   6   5 
NOT COMPLETED   0   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fish Oil, Ablation

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.

Total Total of all reporting groups

Baseline Measures
   Fish Oil, Ablation   Placebo, Ablation, Sinus Rhythm   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age [1] 
[Units: Years]
Mean (Full Range)
     
Participants Analyzed 
[Units: Participants]
 6   5   11 
   56 
 (43 to 64) 
 48.8 
 (26 to 65) 
 52.7 
 (26 to 65) 
[1] One age for one participant randomized to this arm is unavailable. This participant actually never began placebo.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 6   6   12 
Female      0   0.0%      1  16.7%      1   8.3% 
Male      6 100.0%      5  83.3%      11  91.7% 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 6   6   12 
United States   6   6   12 


  Outcome Measures

1.  Primary:   Freedom From Atrial Arrhythmias at 6 Months Will be Defined as Absence of Any Atrial Arrhythmias   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The Study was terminated before subject enrollment completion, due to financial concerns and loss of major support from the 21-day cardiac monitoring device. So small sample size means data should be interpreted with great caution.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Hakan Oral
Organization: University of Michigan
phone: 734 936-6868
e-mail: oralh@med.umich.edu



Responsible Party: Hakan Oral, University of Michigan
ClinicalTrials.gov Identifier: NCT00791089     History of Changes
Other Study ID Numbers: LVZ111900
Study First Received: November 13, 2008
Results First Received: March 24, 2017
Last Updated: March 24, 2017