Cardiac Surgery and the Risk of Atrial Fibrillation: an Intervention Trial Evaluating Melatonin

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

Atrial fibrillation is a common heart rhythm condition that can occur after cardiac surgery and has been associated with an increase in hospital length of stay, overall hospital costs, worsening clinical condition and higher rates of death. Newer research indicates that inflammation is a key contributor to atrial fibrillation in this setting. Melatonin is a naturally made hormone that is regarded as an extremely effective anti-inflammatory substance, with a very favorable safety profile. This clinical trial is being done to test the ability of melatonin to reduce the risk of developing atrial fibrillation after cardiac surgery. This is a research study where patients will be given either oral melatonin at 40 mg or placebo nightly prior to sleep. The study product will start approximately 2 days prior to the scheduled surgery date and will continue until the 3rd day after the operation. The remainder of the clinical care will remain the same. The investigators project that patients who receive melatonin will have a significant decrease in the occurrence of atrial fibrillation after surgery.

Key facts

Study ID

NCT02099331

Run by

Johns Hopkins University

People needed

0

Starts

2014-09-01

Expected to finish

2015-07-06

Last updated by the study team

2021-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age over the age of 18.
• Scheduled for elective cardiac surgery (coronary artery bypass grafting, valvular surgery or combined procedures)
• Enroll at least 48 hours before surgery is scheduled
• Presence of normal sinus rhythm on screening electrocardiogram.
• Be willing to provide informed consent (which may be provided by a legally authorized representative if the patient is not able to do so).

You may not qualify if…

• History of prior atrial fibrillation
• Inability to give informed consent.
• Use of anti-arrhythmic drugs other than beta-blockers
• Chronic NSAID or antioxidant use
• History of severe autoimmune disorders with the need for autoimmune medications.
• History of epilepsy.
• Compromised hepatic function (aminotransferase levels > 1.5 times the upper limit of normal)
• Current pregnancy (determined by either serum or urine pregnancy test, as ordered by the primary team)
• Non-English Speakers
• Current use of warfarin, nifedipine, fluvoxamine.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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