Atrial FibrillationPhase 4NCT00552084
Evaluating the Effectiveness of Fish Oil Supplements at Reducing the Recurrence of Atrial Fibrillation
A Phase 4 study testing Fish oil in people with Atrial Fibrillation, run by Vanderbilt University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Apr 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=21 years of age
- a history of atrial fibrillation
- a history of at least two occurrences of atrial fibrillation or atrial flutter, at least one of which is atrial fibrillation
- an electrocardiogram that was recorded within 12 months of randomization showing atrial fibrillation or atrial flutter
- sinus rhythm at the time the first dose of randomized medication is taken
- stable antiarrhythmic medications
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- if the patient has had an ablation for atrial fibrillation or flutter or a MAZE procedure, the qualifying episode of atrial fibrillation must have occurred at least 3 months post-procedure
- normal serum potassium level within the last 28 days
- provided informed consent
Who cannot join
- permanent atrial fibrillation or flutter
- New York Heart Association class III or IV heart failure or Canadian Cardiovascular Society class III or IV angina pectoris
- cardiac or thoracic surgery within the previous 3 months
- acute pericarditis within the previous 3 months
- other reversible causes of atrial fibrillation such as thyrotoxicosis
- acute myocardial infarction or unstable angina within the previous 3 months
Show all 24Show fewer
- history of neurologic event (TIA or stroke)within the past 3 months
- history of acute congestive heart failure precipitated by atrial fibrillation, and the patient is not receiving rate-control therapy
- Wolff-Parkinson-White syndrome
- a medical condition that is likely to be fatal in less than one year
- active, uncontrolled co-morbid inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, SLE)
- receiving cytotoxic chemotherapy or radiotherapy for cancer
- taking a fish oil supplement
- allergic to fish
- bleeding event not related to trauma or surgery requiring hospitalization or transfusion in previous year
- systolic blood pressure < 90 mm Hg or heart rate <50 beats/minute
- history of ventricular fibrillation or sustained ventricular tachycardia, or presence of an implanted defibrillator placed for the occurrence of such an event or the presence of an Implantable Cardioverter-Defibrillator (ICD) that has discharged appropriately for a ventricular arrhythmia
- pregnant or breast feeding
- enrollment in another research study involving an intervention
- on dialysis or recipient of a renal transplant
- use of potentially cardiotoxic illegal drugs (cocaine, methamphetamine, opioids) in the last 12 months
- Treated for alcoholism and currently drinking alcohol to excess or alcoholic cardiomyopathy as the primary clinical diagnosis and currently drinking alcohol to excess
- presence of an iron-storage disease, such as hemochromatosis, transfusional hemosiderosis, or those subjects in whom a daily dose of up to 20 mg elemental iron (in and of itself or in addition of current iron supplementation) would post a risk for toxicity from iron overload
- subjects receiving or anticipated to receive intravenous iron therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Medical School
Nashville, Tennessee, 37232
About this study
Official title: Fish Oil for Atrial Fibrillation - Effect and Mechanisms
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Fish oil, Placebo
- Keywords
- Fish Oil
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDrug
Also called Lovaza capsule (1 gm)containing 465 mg EPA and 375 mg DHA.
Fish oil supplements 4 gms will be taken daily for 24 weeks.
PlaceboDrug
Also called Corn oil
Placebo supplements will be taken daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil | Experimental | 4 grams fish oil daily for 24 weeks Receives: Drug: Fish oil |
| Placebo | Placebo comparator | corn oil taken daily for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Week 24 or exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), eCardio Diagnostics, GlaxoSmithKline
- Responsible party
- Principal investigator, C. Michael Stein, Vanderbilt University
- Investigators
- Charles M. Stein, Principal investigator, Vanderbilt Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552084
- Sponsor's protocol ID
- 543
- Other IDs
- R01HL087254, HL 087254
- Status last verified
- Nov 2014
- First submitted
- 31 Oct 2007
- Last updated
- 3 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25465932
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil for Atrial Fibrillation - Effect and Mechanisms
- ClinicalTrials.gov ID
- NCT00552084
- Acronym / sponsor ID
- 543
- Conditions
- Atrial Fibrillation
- Keywords
- Fish Oil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), eCardio Diagnostics, GlaxoSmithKline
- Study start
- Nov 2007
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Posted 18 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Experimental | Drug: Fish oil4 grams fish oil daily for 24 weeks |
| Placebo | Placebo comparator | Drug: Placebocorn oil taken daily for 24 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >=21 years of age
- a history of atrial fibrillation
- a history of at least two occurrences of atrial fibrillation or atrial flutter, at least one of which is atrial fibrillation
- an electrocardiogram that was recorded within 12 months of randomization showing atrial fibrillation or atrial flutter
- sinus rhythm at the time the first dose of randomized medication is taken
Key exclusion criteria (24 listed)
- permanent atrial fibrillation or flutter
- New York Heart Association class III or IV heart failure or Canadian Cardiovascular Society class III or IV angina pectoris
- cardiac or thoracic surgery within the previous 3 months
- acute pericarditis within the previous 3 months
- other reversible causes of atrial fibrillation such as thyrotoxicosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilAlso: Lovaza capsule (1 gm)containing 465 mg EPA and 375 mg DHA.Fish oil supplements 4 gms will be taken daily for 24 weeks. | Drug | Fish Oil |
| PlaceboAlso: Corn oilPlacebo supplements will be taken daily for 24 weeks. | Drug | Placebo |
Primary outcome
Documented Recurrence of Atrial Fibrillation/Atrial Flutter
Time frame: Measured at Week 24 or exit
Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25465932Vanderbilt 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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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles M. Stein principal investigator
Vanderbilt Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fish oil in people with Atrial Fibrillation, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documented Recurrence of Atrial Fibrillation/Atrial Flutter (time frame: Measured at Week 24 or exit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.