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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

November 13, 2008
March 24, 2017
November 2008
December 2009   (Final data collection date for primary outcome measure)
Freedom From Atrial Arrhythmias at 6 Months Will be Defined as Absence of Any 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
Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias without antiarrhythmic drug therapy. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00791089 on ClinicalTrials.gov Archive Site
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Effects of Fish Oil on Post Ablation Arrhythmias
Effect of Omega-3 Fatty Acids on Short and Long-Term Maintenance of Sinus Rhythm After Radiofrequency Catheter Ablation for Atrial Fibrillation
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Atrial Fibrillation
  • 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.
  • Other: placebo
    Control group will receive placebo before & after ablation.
  • 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.
    Interventions:
    • Drug: LOVAZA Omega 3-acid ethyl esters
    • Drug: LOVAZA
  • Placebo Comparator: placebo, Ablation, sinus rhythm
    Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
    Intervention: Other: placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
October 2011
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00791089
LVZ111900
Yes
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Hakan Oral, University of Michigan
University of Michigan
GlaxoSmithKline
Principal Investigator: Hakan Oral, MD University of Michigan Hospital
University of Michigan
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP