Clinical Trial: Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

Brief Summary: The primary objective of this research is to determine whether oral magnesium supplementation in healthy, community-living individuals will be associated with reductions in the burden of arrhythmias in the upper chambers of the heart (supraventricular arrhythmias).

Detailed Summary: To evaluate the primary objective, the Investigator will conduct a double-blind randomized trial assigning participants to receive 400 mg of oral magnesium in the form of magnesium citrate once daily or placebo. The investigators will recruit 60 individuals 55 years of age and older without a prior history of cardiovascular disease. At baseline, participants will undergo a basic examination, answer questionnaires and provide a blood sample to determine circulating magnesium levels. Participants will then wear an FDA-approved heart rhythm monitor (Zio ® XT Patch) for 2 weeks. At the end of 2 weeks they will begin taking their assigned treatment (magnesium or placebo), and will continue doing so for a total of 12 weeks (through study week 14). After 10 weeks of taking the supplement or placebo (study week 12), they will have a final study visit in which the participants will provide another blood sample for assessment of circulating magnesium, and will be asked to wear the heart rhythm monitor for another 2 weeks (through study week 14). The primary endpoint will be the change in burden of premature atrial contractions (PACs), measured in episodes per day, between baseline and final follow-up visit. A secondary outcome will be the change in circulating magnesium between both exams.
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: Change in Premature Atrial Contractions (PACs) [ Time Frame: Change from Baseline at 4 weeks ]

The primary endpoint will be the change in burden of PACs


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in Magnesium concentration [ Time Frame: Baseline and week 12 ]

The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 12 weeks later.


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: June 22, 2016
Date Started: March 1, 2017
Date Completion: December 2018
Last Updated: March 31, 2017
Last Verified: March 2017