Atrial Fibrillation Clinical Trial
— DREAMOfficial title:
Cardiac Surgery and the Risk of Atrial Fibrillation: an Intervention Trial Evaluating Melatonin
Verified date | August 2021 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 6, 2015 |
Est. primary completion date | July 6, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age over the age of 18. 2. Scheduled for elective cardiac surgery (coronary artery bypass grafting, valvular surgery or combined procedures) 3. Enroll at least 48 hours before surgery is scheduled 4. Presence of normal sinus rhythm on screening electrocardiogram. 5. Be willing to provide informed consent (which may be provided by a legally authorized representative if the patient is not able to do so). Exclusion Criteria: 1. History of prior atrial fibrillation 2. Inability to give informed consent. 3. Use of anti-arrhythmic drugs other than beta-blockers 4. Chronic NSAID or antioxidant use 5. History of severe autoimmune disorders with the need for autoimmune medications. 6. History of epilepsy. 7. Compromised hepatic function (aminotransferase levels > 1.5 times the upper limit of normal) 8. Current pregnancy (determined by either serum or urine pregnancy test, as ordered by the primary team) 9. Non-English Speakers 10. Current use of warfarin, nifedipine, fluvoxamine. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | The investigators will measure the incidence of MACE (need for redo surgery, acute heart failure, death or malignant arrhythmias) as well hepatic dysfunction and renal failure in each arm of the study. | 2 years | |
Other | Impact on Sleep | The investigators will measure how the intervention may impact the amount of sleep patients attain in the first 72 hours after surgery. This outcome measure will be compared between the arms at the end of the study. | 2 years | |
Primary | Incidence of atrial fibrillation | At the end of the study, the primary outcome of incident atrial fibrillation will be assessed in each study arm. | 2 years | |
Secondary | Levels of Reactive Oxygen Species (ROS) | The investigators will measure levels of ROS from the right atrial appendage and serum samples at the time of surgery as well as on a daily basis from the serum for three days after surgery. Specifically, the investigators will measure NADPH oxidase, peroxide anion, peroxynitrite and thiobarbituric acid reactive substances. At the end of the study, the investigators will compare these levels in both arms. | 2 years |
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