Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

Premature Atrial Contraction Clinical Trial

Official title:

Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837328
• Other study ID #: 1605M87323
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2017
• Est. completion date: September 15, 2017

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Age 55 and older

• Ability to speak English

• Availability to attend baseline and follow-up visit approximately 12 weeks after baseline

Exclusion Criteria:

• Prior history of heart disease (coronary heart disease, heart failure, atrial fibrillation), stroke, severe renal disease

• Use of type I and III antiarrhythmics or digoxin

• Current use of magnesium supplements

• Any prior history of allergy or intolerance to magnesium

• Prior history of inflammatory bowel disease or any severe gastrointestinal disorder

Related Conditions & MeSH terms

• Atrial Premature Complexes
• Premature Atrial Contraction

Intervention

Drug:
• Oral Magnesium Supplement
400 mg Magnesium Citrate 1x daily for 12 weeks
• Placebo
Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks

Locations

Country	Name	City	State
United States	University of Minnesota - Twin Cities	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Premature Atrial Contractions (PACs)	The primary endpoint will be the change in burden of PACs	Change from Baseline at 10 weeks
Secondary	Change in Magnesium Concentration	The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later.	Baseline and week 10