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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
  Purpose
To determine if peri-operative treatment with omega-3 fatty acids is associated with a decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an improvement in probability of long-term maintenance of sinus rhythm after radiofrequency catheter ablation for Atrial Fibrillation.

Condition Intervention Phase
Atrial Fibrillation Drug: LOVAZA Omega 3-acid ethyl esters Drug: LOVAZA Other: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Omega-3 Fatty Acids on Short and Long-Term Maintenance of Sinus Rhythm After Radiofrequency Catheter Ablation for Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Hakan Oral, University of Michigan:

Primary Outcome Measures:
  • Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias) [ Time Frame: 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


Enrollment: 12
Study Start Date: November 2008
Study Completion Date: October 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Names:
  • Fish Oil
  • Lovaza
Drug: LOVAZA
(EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.
Placebo Comparator: placebo, Ablation, sinus rhythm
Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
Other: placebo
Control group will receive placebo before & after ablation.

Detailed Description:
AF is the most prevalent arrhythmia, affecting >2 million Americans. Antiarrhythmic drug therapy often is ineffective to eliminate recurrent episodes of AF. In recent years radiofrequency catheter ablation has emerged as a highly effective treatment strategy in patients with paroxysmal and chronic AF.6, 7 However, AF may recur within days to weeks after a successful ablation procedure in up to 50% of the patients, probably because of an inflammatory response to thermal injury caused by radiofrequency energy application. These early recurrences of AF after ablation do not necessarily predict long-term clinical outcome and 30-50% of patients who develop early recurrences ultimately remain in sinus rhythm without the need for additional ablation.8 However, early recurrences of AF may be associated with significant morbidity due to troubling symptoms of rapid ventricular rates, multiple hospital visits and cardioversions, need for antiarrhythmic drug therapy and prolongation in duration of anticoagulant therapy. It is also possible that if early recurrences of AF after ablation can be avoided, the probability of remaining in sinus rhythm during long-term follow-up may be higher, as maintenance of sinus rhythm early-on may facilitate reverse left atrial remodeling. A similar phenomenon may occur in post-operative AF, that develops in ~30% of patients who undergo cardiac surgery. Post-operative AF is often transient and usually resolves within 3 months after the surgery. Perioperative treatment with omega-3 fatty acids has been reported to decrease the incidence of postoperative AF after coronary artery by-pass surgery.4 Because the pathogenetic factors that play a role in postoperative AF and early recurrences of AF after radiofrequency catheter ablation may be similar, it is plausible that treatment with omega-3 fatty acids before and after ablation will be associated with a reduction in the incidence of early recurrences of AF.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years and < 70 years old
  • Left atrial size <55 mm

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent
  • Current therapy with omega-3 fatty acids
  • Current therapy with a statin
  • Active liver disease
  • Significant comorbidity such as end-stage renal disease or cirrhosis
  • Valvular prosthesis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791089


Locations
United States, Michigan
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
GlaxoSmithKline
Investigators
Principal Investigator: Hakan Oral, MD University of Michigan Hospital
  More Information

Responsible Party: Hakan Oral, Cardiology EP Director, 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
Last Verified: August 2017

Keywords provided by Hakan Oral, University of Michigan:
Radiofrequency Ablation
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes


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