Effects of Fish Oil on Post Ablation Arrhythmias

NCT00791089 | Terminated Phase 4 Results DMC

• 1 other identifier: LVZ111900
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Radiofrequency Ablation; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias)

  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

  6 months

Study Arms (2)

Fish Oil, Ablation, Sinus Rhythm

EXPERIMENTAL

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; Drug: LOVAZA

placebo, Ablation, sinus rhythm

PLACEBO COMPARATOR

Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.

Other: placebo

Interventions

LOVAZA Omega 3-acid ethyl esters DRUG

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

Also known as: Fish Oil, Lovaza

Fish Oil, Ablation, Sinus Rhythm

LOVAZA DRUG

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

Fish Oil, Ablation, Sinus Rhythm

placebo OTHER

Control group will receive placebo before \& after ablation.

placebo, Ablation, sinus rhythm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Fish Oils; Omacor

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Limitations and Caveats

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.

Results Point of Contact

• Title: Hakan Oral
• Organization: University of Michigan

oralh@med.umich.edu

734 936-6868

Study Officials

• Hakan Oral, MD

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology EP Director

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: October 1, 2011
• Last Updated: September 12, 2017
• Results First Posted: May 5, 2017

Record last verified: 2017-08

Locations

US (1)