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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
n-3 PUFAs
Placebo
RASS inhibitors and/or RAS blockers
Amiodarone
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring PUFA atrial fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Arrhytmias and Heart failure Unit-Spedali Civili Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

n-3 PUFAs

placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence
The mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.

Full Information

First Posted
September 9, 2010
Last Updated
January 19, 2012
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT01198275
Brief Title
n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
Official Title
N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Atrial fibrillation (AF) is the most common sustained arrhythmia and represents an increasing burden on the healthcare system. Treatment of AF remains controversial. In patients on antiarrhythmic therapy, the one-year relapse rates of AF after cardioversion ranges from 44% to 77% at one year and amiodarone appears to the be the most effective in maintaining sinus rhythm.Over the last few years, a growing amount of evidences has supported the protective effects of n-3 PUFAs in preventing ventricular arrhythmias and reducing the risk of sudden cardiac death. Furthermore, in the last years, the interest for their possible beneficial role in AF prevention has been increasing.We hypothesized that the administration of n-3 PUFAs could reduce the AF recurrence rate more than amiodarone plus RAAS inhibitors in patients with persistent AF. Therefore the present study aims to evaluate the role of n-3 PUFAs in the prophylaxis of AF recurrences after DCCV in addition to amiodarone and RAS blockers therapy in patients with persistent AF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
PUFA atrial fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
n-3 PUFAs
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
n-3 PUFAs
Other Intervention Name(s)
OMACOR
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1.0 g of olive oil,one capsule twice a day
Intervention Type
Drug
Intervention Name(s)
RASS inhibitors and/or RAS blockers
Other Intervention Name(s)
renin-angiotensin-aldosterone system inhibitor
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence
Description
The mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.
Time Frame
1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: persistent Atrial Fibrillation (AF) lasting > one month history of at least one AF relapse after previous electrical or Pharmacological cardioversion Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savina Nodari, MD
Organizational Affiliation
Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Livio Dei Cas, MD
Organizational Affiliation
Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
Official's Role
Study Director
Facility Information:
Facility Name
Arrhytmias and Heart failure Unit-Spedali Civili Hospital
City
Brescia
ZIP/Postal Code
25100
Country
Italy

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background
PubMed Identifier
21844082
Citation
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.
Results Reference
derived
Links:
URL
http://www.theheart.org
Description
interview during American College of Cardiology 2010 convention

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

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