Effects of Fish Oil on Post Ablation Arrhythmias

NCT ID: NCT00791089

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-10-31

Brief Summary

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

LOVAZA Omega 3-acid ethyl esters

Intervention Type: DRUG

Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.

LOVAZA

Intervention Type: DRUG

(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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Control group will receive placebo before \& after ablation.

Interventions

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.

Intervention Type: DRUG

LOVAZA

(EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.

Intervention Type: DRUG

placebo

Control group will receive placebo before \& after ablation.

Intervention Type: OTHER

Other Intervention Names

Fish Oil; Lovaza

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Hakan Oral

Cardiology EP Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hakan Oral, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital

Locations

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

LVZ111900

Identifier Type: -

Identifier Source: org_study_id