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

NCT02099331 | Withdrawn Phase 2 DMC

• 1 other identifier: NA_00090647
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Reactive Oxygen Species; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Levels of Reactive Oxygen Species (ROS)

  2 years

Other Outcomes (2)

• Adverse Events

  2 years

• Impact on Sleep

  2 years

Study Arms (2)

Melatonin

EXPERIMENTAL

The investigators will administer melatonin at 40mg by mouth (two 20 mg tablets), nightly prior to sleep. The administration will start 2 days prior to the scheduled surgery date and will continue until post-operative day 3.

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

The investigators will administer matching Placebo by mouth (two tablets to match Melatonin), nightly prior to sleep. The administration will start 2 days prior to the scheduled surgery date and will continue until post-operative day 3.

Drug: Placebo (for Melatonin)

Interventions

Melatonin DRUG

Also known as: N - acetyl - 5 - methoxytryptamine

Melatonin

Placebo (for Melatonin) DRUG

Sugar pill manufactured to mimic Melatonin 20 mg

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Oscar Cingolani, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2014
• First Posted: March 28, 2014
• Study Start: September 1, 2014
• Primary Completion: July 6, 2015
• Study Completion: July 6, 2015
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

US (1)