Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Premature Atrial Contraction

Treatments: Drug: Placebo; Drug: Oral Magnesium Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02837328

1605M87323

Details and patient eligibility

About

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).

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 2 patient groups, including a placebo group

Oral Magnesium Supplement

Experimental group

Description:

400 mg Magnesium Citrate 1x daily for 12 weeks

Treatment:

Drug: Oral Magnesium Supplement

Placebo

Placebo Comparator group

Description:

Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks

Treatment:

Drug: Placebo