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

NCT02099331 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-08-12

No results posted yet for this study

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

Interventions

DRUG

Melatonin

DRUG

Placebo (for Melatonin)

Sugar pill manufactured to mimic Melatonin 20 mg

Sponsors & Collaborators

Principal Investigators

  • Oscar Cingolani, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-07-06
Completion
2015-07-06

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099331 on ClinicalTrials.gov