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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL087254 | U.S. NIH Grant/Contract | View source | |
| HL 087254 |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| eCardio Diagnostics | UNKNOWN |
| GlaxoSmithKline | INDUSTRY |
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Atrial fibrillation (AF) is a heart rhythm disorder that usually involves a rapid heart rate. People who take fish oil supplements may reduce the risk of a recurrence of AF. This study will evaluate the effectiveness of fish oil at decreasing the recurrence of AF and will examine the reasons why fish oil may reduce this risk.
AF is the most common type of serious heart arrhythmia. It affects approximately 2% of the population and is becoming more common. In AF, the heart's atria, or upper chambers, contract in a very disorganized and abnormal manner and are unable to correctly pump blood into the heart's ventricles, or lower chambers. Symptoms may include a rapid or irregular pulse, dizziness, fainting, or breathing difficulty. Recent studies suggest that inflammation plays a fundamental role in the development of AF. Inflammation, and the resulting oxidative stress, can cause cellular and tissue damage. In turn, this may alter heart function, potentially leading to both the onset and recurrence of AF. Markers of inflammation, such as C-reactive protein (CRP) and interleukin-6 (IL-6), are often elevated in patients with AF, providing further evidence of inflammation's role. While there are several treatment options for AF, they are usually only moderately effective. Previous research has shown that fish oil supplements have anti-inflammatory, antifibrotic, and antioxidant effects and can reduce the risk of AF following surgery. However, it is not known exactly how fish oil reduces this risk and whether the same positive effect will carry over in people who experience the more common type of AF that is unrelated to surgery. The purpose of this study is to evaluate the effectiveness of fish oil supplementation at decreasing the recurrence of AF in adults who have not undergone recent surgery. Researchers will also examine the ways in which fish oil reduces AF recurrence.
This study will enroll people who have had at least two occurrences of AF. Participants will be randomly assigned to receive either fish oil supplements or placebo for 24 weeks. At study visits at baseline and Weeks 2, 4, 8, 12, 18, and 24, participants will undergo a medical and social history review, a physical exam, and blood and urine collection. At the baseline study visit, an electrocardiogram will also occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish Oil | Experimental | 4 grams fish oil daily for 24 weeks |
|
| Placebo | Placebo Comparator | corn oil taken daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil | Drug | Fish oil supplements 4 gms will be taken daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Documented Recurrence of Atrial Fibrillation/Atrial Flutter | Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia. | Measured at Week 24 or exit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles M. Stein | Vanderbilt Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Medical School | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25465932 | Derived | Vanderbilt C, Free M, Li J, Gebretsadik T, Bian A, Shintani A, McBride BF, Solus J, Milne G, Crossley GH, Thompson D, Vidaillet H, Okafor H, Darbar D, Murray KT, Stein CM. Effect of omega-three polyunsaturated fatty acids on inflammation, oxidative stress, and recurrence of atrial fibrillation. Am J Cardiol. 2015 Jan 15;115(2):196-201. doi: 10.1016/j.amjcard.2014.10.022. Epub 2014 Oct 29. |
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Patients were >= 21 years old with a history of at least 2 occurrences of atrial fibrillation or atrial flutter, and in sinus rhythm at randomization. Randomization was performed according to a computer-generated block scheme according to anti-arrhythmic therapy: 1. no therapy, 2. amiodarone, 3. class 1 anti-arrhythmic drugs, 4.sotalol/dofetilide.
Participants were recruited at 4 medical centers in Nashville Tennessee, and at the Marsh field Clinic in Madison, Wisconsin. Between December 2007 and December 2012, 241 patients were enrolled and 190 (178 at Vanderbilt, 12 at other sites) were randomized to fish oil (126) or placebo (64). Of 190 enrolled, 173 (91%) completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fish Oil | 4 grams fish oil daily for 24 weeks Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks. |
| FG001 | Placebo | corn oil taken daily for 24 weeks Placebo: Placebo supplements will be taken daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fish Oil | 4 grams fish oil daily for 24 weeks Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks. |
| BG001 | Placebo | corn oil taken daily for 24 weeks Placebo: Placebo supplements will be taken daily for 24 weeks. |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Documented Recurrence of Atrial Fibrillation/Atrial Flutter | Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia. | Posted | Number | percentage of participants | Measured at Week 24 or exit |
|
Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.
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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 | Fish Oil | 4 grams fish oil daily for 24 weeks Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pseudogout | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low INR | Blood and lymphatic system disorders | Non-systematic Assessment |
We determined recurrence of Atrial Fibrillation(AF) by both routine and symptomatic TTM transmissions. We did not examine the effect of therapy on total AF burden. Sample size was relatively small, and included a heterogeneous patient population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. C Michael Stein | Vanderbilt University Medical Center | 615-936-3420 | mike.stein@vanderbilt.edu |
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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 |
|---|---|
| D005395 | Fish Oils |
| C405603 | Omacor |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
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| Placebo | Drug | Placebo supplements will be taken daily for 24 weeks. |
|
|
| Protocol Violation |
|
| change in anti-arrythmic drug |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 2 |
| 126 |
| 40 |
| 126 |
| EG001 | Placebo | corn oil taken daily for 24 weeks Placebo: Placebo supplements will be taken daily for 24 weeks. | 3 | 64 | 13 | 64 |
| non-cardiac chest pain | General disorders | Non-systematic Assessment |
|
| acute coronary syndrome | Cardiac disorders | Non-systematic Assessment |
|
| bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| rapid atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005223 |
| Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |