Effects of Fish Oil on Post Ablation Arrhythmias

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00791089
First received: November 13, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 University of Michigan:

Primary Outcome Measures:
  • Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias without antiarrhythmic drug therapy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: October 2010
Estimated 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791089

Contacts
Contact: Jacqueline J Fortino, RN /BSN 734-615-2680 jfortino@umich.edu

Locations
United States, Michigan
University of Michigan Cardiovascular Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jacqueline Fortino, RN / BSN    734-615-2680    jfortino@umich.edu   
Sponsors and Collaborators
University of Michigan
GlaxoSmithKline
Investigators
Principal Investigator: Hakan Oral, MD University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Hakan Oral MD, University of Michigan
ClinicalTrials.gov Identifier: NCT00791089     History of Changes
Other Study ID Numbers: LVZ111900
Study First Received: November 13, 2008
Last Updated: November 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Radiofrequency Ablation
atrial fibrillation

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

ClinicalTrials.gov processed this record on July 22, 2014