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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| n-3 PUFAs | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhytmias and Heart failure Unit-Spedali Civili Hospital | Brescia | Brescia | 25100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 21844082 | Derived | 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. |
| Label | URL |
|---|---|
| interview during American College of Cardiology 2010 convention | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | n-3 PUFAs | 1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily |
| FG001 | Placebo | 1.0 g placebo gelatine capsules(olive oil)twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | n-3 PUFAs | 1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Not Posted | Jul 2011 | Mean | Standard Deviation | time | 1, 3 and 6 months | ||||||||
| Primary | 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. |
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | n-3 PUFAs | 1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Savina Nodari | Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases | 00390303996 | 587 | nodari@med.unibs.it |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | 1.0 g of olive oil,one capsule twice a day |
|
| 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. |
|
|
| 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. |
|
1.0 g placebo gelatine capsules(olive oil)twice daily
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mar 2010 |
| Number |
| partecipants |
| one year |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Placebo | 1.0 g placebo gelatine capsules(olive oil)twice daily | 0 | 99 | 0 | 99 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |