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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:
ClinicalTrials.gov Identifier:
NCT00791089
First Posted: November 14, 2008
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Hakan Oral, University of Michigan
Results First Submitted: March 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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
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.

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 
Began Actually Taking Fish Oil or Placeb   6   5 
Six-month Data Collected   6   5 
COMPLETED   0   0 
NOT COMPLETED   6   6 



  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.
Baseline analysis is provided for all persons who actually began their assignment.

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   5   11 
Age [1] 
[Units: Years]
Mean (Full Range)
 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
     
Female      0   0.0%      1  20.0%      1   9.1% 
Male      6 100.0%      4  80.0%      10  90.9% 
Region of Enrollment 
[Units: Participants]
     
United States   6   5   12 


  Outcome Measures

1.  Primary:   Number of Participants With Normal Sinus Rhythm (Freedom From 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
First Submitted: November 13, 2008
First Posted: November 14, 2008
Results First Submitted: March 24, 2017
Results First Posted: May 5, 2017
Last Update Posted: September 12, 2017



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