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Atrial FibrillationPhase 3OPERANCT00970489

Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation

A Phase 3 study testing Omega -3 fatty acids in people with Atrial Fibrillation, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a large multi-center study to examine whether peri-operative intake of n-3 polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Omega -3 fatty acids
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,516 participants
Where
1 siteUnited States
Study dates
Aug 2010to Jun 2012
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or over
  • Scheduled for CS on the following day or later, including coronary artery bypass, valve surgery, any other open cardiac surgery (i.e., that includes opening of the pericardium), or any combination.
  • Sinus rhythm on current ECG (sinus bradycardia, sinus tachycardia, and ectopy are acceptable).

Who cannot join

  • Regular use (3 or more days/week) of fish oil within the past 4 weeks.
  • Known allergy or intolerance to fish oil or corn oil.
  • Currently pregnant.
  • Unable to provide informed written consent.
  • Current or planned cardiac transplant or LVAD

Trial locations and contacts

1 site in 1 country.

United States1 site

  • US, Italy and Argentina

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: (OPERA)Randomized Clinical Trial to Examine Whether Peri-operative Intake of n-3 Polyunsaturated Fatty Acids Will Reduce the Occurrence of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

This is a large multi-center study to examine whether peri-operative intake of n-3 polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).

Being tested
Omega -3 fatty acids, Placebo
Keywords
atrial fibrillation, 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.

  • Omega -3 fatty acidsDrug

    10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.

  • PlaceboDrug

    Olive Oil capsules

Study groups in NCT00970489
Study groupRoleWhat they receive
Omega-3 fatty acid capsulesExperimentalNot described
Receives: Drug: Omega -3 fatty acids
Olive Oil capsulePlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any First Post-op Atrial Fibrillation or Flutter (AF)

    Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics).

    Measured: up to 10 days post-surgery or discharge, whichever sooner

Secondary outcomes (3)

  1. Post-op Af

    Secondary AF endpoints included post-op AF that was sustained (>1 hour), symptomatic, or treated with pharmacological or electrical cardioversion; post-op AF excluding atrial flutter; time to first post-op AF; and the number of post-op AF episodes per patient. OPERA also evaluated the total number of in-hospital days in which any post-op AF, including sustained post-op AF, was present; and the proportion of in-hospital days free of any post-op AF. All potential episodes of post-op AF and other tachyarrhythmias were reviewed and adjudicated by a centralized Events Committee of cardiac electrophysiologists. Additional endpoints included resource utilization, major adverse cardiovascular events (MACE), arterial thromboembolism, and 30-day mortality.

    Measured: up to 10 days post-surgery or discharge, whichever sooner

  2. Other Arrhythmias

    • The first 3 suspected episodes of atrial fibrillation or flutter of at least 30 sec duration following randomization were documented, including the following information:
    • Printed or digital rhythm strip and/or 12-lead ECG.
    • Recording of time of onset and time of cessation.
    • Additional documentation of temporally associated signs of symptoms, such as new or worsening chest pain, shortness of breath, or lightheadedness; drop in blood pressure requiring escalation of fluid or pressor treatment; or need for electrical or pharmacologic cardioversion.
    • The first suspected episode of each of other supraventricular or unknown narrow-complex tachycardia of at least 30 sec duration following randomization was also documented.

    Measured: up to 10 days post-surgery or discharge, whichever sooner

  3. Other Endpoints

    1. Number of days in the ICU, of telemetry monitoring, and of total hospital stay.
    2. Non-AF arrhythmias of at least 30 sec duration, including non-AF-SVT, ventricular tachycardia (VT), and ventricular flutter (VF), assessed and adjudicated by the Events Committee.
    3. MACE: Combined total mortality, myocardial infarction, and stroke.
    4. Bleeding, assessed by (a) chest tube output in the 24 hour period following surgery and (b) total number of packed red blood cell (RBC) transfusions from enrollment to end of treatment (hospital discharge or post-op day 10).
    5. Significant adverse events: Discontinuation of study treatment, at the discretion of the treating physicians, for suspected significant allergic reaction, severe gastrointestinal intolerance, significant bleeding, or other side effects requiring discontinuation.
    6. Thirty-day mortality assessed
    7. One-year mortality assessed

    Measured: up to 10 days post-surgery or discharge, whichever sooner

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2009 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2012
  4. Study completionJun 2012

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00970489
Sponsor's protocol ID
IND-104364
Acronym
OPERA
Status last verified
Feb 2017
First submitted
31 Aug 2009
Last updated
10 Apr 2017
Data monitoring committee
Yes

Publications

  • Akintoye E, Sethi P, Harris WS, Thompson PA, Marchioli R, Tavazzi L, Latini R, Pretorius M, Brown NJ, Libby P, Mozaffarian D. Fish Oil and Perioperative Bleeding. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004584. doi: 10.1161/CIRCOUTCOMES.118.004584.

    PubMed 30571332

  • Jackson JC, Mozaffarian D, Graves AJ, Brown NJ, Marchioli R, Kiehl AL, Ely EW. Fish Oil Supplementation Does Not Affect Cognitive Outcomes in Cardiac Surgery Patients in the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA) Trial. J Nutr. 2018 Mar 1;148(3):472-479. doi: 10.1093/jn/nxx002.

    PubMed 29546292

  • Wu JH, Marchioli R, Silletta MG, Masson S, Sellke FW, Libby P, Milne GL, Brown NJ, Lombardi F, Damiano RJ Jr, Marsala J, Rinaldi M, Domenech A, Simon C, Tavazzi L, Mozaffarian D. Oxidative Stress Biomarkers and Incidence of Postoperative Atrial Fibrillation in the Omega-3 Fatty Acids for Prevention of Postoperative Atrial Fibrillation (OPERA) Trial. J Am Heart Assoc. 2015 May 20;4(5):e001886. doi: 10.1161/JAHA.115.001886.

    PubMed 25994442

  • Wu JH, Marchioli R, Silletta MG, Macchia A, Song X, Siscovick DS, Harris WS, Masson S, Latini R, Albert C, Brown NJ, Lamarra M, Favaloro RR, Mozaffarian D. Plasma phospholipid omega-3 fatty acids and incidence of postoperative atrial fibrillation in the OPERA trial. J Am Heart Assoc. 2013 Oct 21;2(5):e000397. doi: 10.1161/JAHA.113.000397.

    PubMed 24145742

  • Mozaffarian D, Marchioli R, Macchia A, Silletta MG, Ferrazzi P, Gardner TJ, Latini R, Libby P, Lombardi F, O'Gara PT, Page RL, Tavazzi L, Tognoni G; OPERA Investigators. Fish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial. JAMA. 2012 Nov 21;308(19):2001-11. doi: 10.1001/jama.2012.28733.

    PubMed 23128104

  • Mozaffarian D, Marchioli R, Gardner T, Ferrazzi P, O'Gara P, Latini R, Libby P, Lombardi F, Macchia A, Page R, Santini M, Tavazzi L, Tognoni G. The omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design. Am Heart J. 2011 Jul;162(1):56-63.e3. doi: 10.1016/j.ahj.2011.03.035. Epub 2011 Jun 12.

    PubMed 21742090

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omega -3 fatty acids in people with Atrial Fibrillation, run by Brigham and Women's Hospital 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 3 inclusion and 5 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 10 Apr 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Apr 2017). 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?

Any First Post-op Atrial Fibrillation or Flutter (AF) (time frame: up to 10 days post-surgery or discharge, whichever sooner). 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 NCT00970489, which also lists 6 linked publications.

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 10 Apr 2017.

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