n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation

NCT01198275 | Completed Phase 3 Results DMC

• 1 other identifier: CS-PUFA-01
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm after electrical conversion in patients with persistent Atrial fibrillation (AF).

Conditions

Atrial Fibrillation

Keywords

PUFA atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)

  Sinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.

  one year

Secondary Outcomes (1)

• The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence

  1, 3 and 6 months

Study Arms (2)

n-3 PUFAs

ACTIVE COMPARATOR

Drug: n-3 PUFAs; Drug: RASS inhibitors and/or RAS blockers; Drug: Amiodarone

placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: RASS inhibitors and/or RAS blockers; Drug: Amiodarone

Interventions

n-3 PUFAs DRUG

1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day

Also known as: OMACOR

n-3 PUFAs

Placebo DRUG

1.0 g of olive oil,one capsule twice a day

placebo

RASS inhibitors and/or RAS blockers DRUG

Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose.

Also known as: renin-angiotensin-aldosterone system inhibitor

n-3 PUFAs; placebo

Amiodarone DRUG

Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.

n-3 PUFAs; placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persistent Atrial Fibrillation (AF) lasting \> one month
• history of at least one AF relapse after previous electrical or Pharmacological cardioversion

You may not qualify if:

• left atrium size \> 6 cm
• severe valvulopathy
• myocardial infarction during the previous 6 months
• unstable angina
• NYHA heart failure class IV or hemodynamic instability
• cardiac surgery during the previous 3 months
• significant pulmonary thyroid and hepatic disease
• contraindications to treatment with amiodarone or RASS inhibitors
• chronic renal dysfunction
• QT \> 480 msec in the absence of bundle-branch block
• bradycardia \< 50 b/min
• diagnosis of paroxysmal AF
• hyperkalemia
• pregnancy
• any disease or other medical treatment that, in the opinion of the investigators, could interfere with the study.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Arrhytmias and Heart failure Unit-Spedali Civili Hospital

Brescia, Brescia, 25100, Italy

Location

Related Publications (2)

• 1) Go AS, Hylek EM. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 285(18):2370-2375, 2001 2) Wolf PA, Mitchell JB. Impact of atrial fibrillation on mortality, stroke, and medical costs. Arch Intern Med.;158(3):229-234, 1998 3) de Denus S, Sanoski CA. Rate vs rhythm control in patients with atrial fibrillation: a meta-analysis. Arch Intern Med 165(3):258-262, 1998 4) Fuster V, Ryden LE. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation.Europace 8(9):651-745, 2006 5) Nichol G, McAlister F. Meta-analysis of randomised controlled trials of the effectiveness of antiarrhythmic agents at promoting sinus rhythm in patients with atrial fibrillation. Heart 87(6):535-543, 2002 6) Calo L, Bianconi L. N-3 Fatty acids for the prevention of atrial fibrillation after coronary artery bypass surgery: a randomized, controlled trial. J Am Coll Cardiol 45(10):1723-1728, 2005

  BACKGROUND

• Nodari S, Triggiani M, Campia U, Manerba A, Milesi G, Cesana BM, Gheorghiade M, Dei Cas L. n-3 polyunsaturated fatty acids in the prevention of atrial fibrillation recurrences after electrical cardioversion: a prospective, randomized study. Circulation. 2011 Sep 6;124(10):1100-6. doi: 10.1161/CIRCULATIONAHA.111.022194. Epub 2011 Aug 15.

  PMID: 21844082 DERIVED

Related Links

• interview during American College of Cardiology 2010 convention

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Omacor; Amiodarone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The effect of n-3 PUFAs on the recurrence of Atrial Fibrillation (AF) in patients with persistent AF not on amiodarone and a renin-angiotensin-aldosterone system (RASS) inhibitor cannot be inferred from our findings

Results Point of Contact

• Title: Dr. Savina Nodari
• Organization: Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases

nodari@med.unibs.it

00390303996

Study Officials

• Savina Nodari, MD

  Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

• Livio Dei Cas, MD

  Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: January 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 20, 2012
• Results First Posted: July 21, 2011

Record last verified: 2012-01

Locations

IT (1)