Premature Atrial Contraction
Conditions
Keywords
Magnesium Supplementation, Magnesium, Dietary Supplement, Arrhythmia
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 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.
Interventions
DRUGOral Magnesium Supplement
400 mg Magnesium Citrate 1x daily for 12 weeks
DRUGPlacebo
Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Premature Atrial Contractions (PACs) | Change from Baseline at 10 weeks | The primary endpoint will be the change in burden of PACs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Magnesium Concentration | Baseline and week 10 | The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later. |
Countries
United States
Participant flow
Recruitment details
Participants of 55 years of age or older were recruited using fliers, the University of Minnesota StudyFinder website, invitations to individuals enrolled in the ResearchMatch research volunteer database, and invitations to University of Minnesota School of Public Health employees.
Pre-assignment details
Participants attended a baseline visit where measurements were conducted and a Zio XT Patch heart rhythm monitor was applied by trained staff. After wearing the patch for 2 weeks, the participants were randomized 1:1 to either magnesium oxide or a placebo using block randomization within two strata of age (younger than 65 and 65 and older).
Participants by arm
| Arm | Count |
|---|---|
| Oral Magnesium Supplement 400 mg Magnesium Citrate 1x daily for 12 weeks
Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks | 29 |
| Placebo Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
Placebo: Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks | 30 |
| Total | 59 |
Baseline characteristics
| Characteristic | Oral Magnesium Supplement | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 22 Participants | 45 Participants |
| Age, Continuous | 61.3 years STANDARD_DEVIATION 5.3 | 61.6 years STANDARD_DEVIATION 5.2 | 61.5 years STANDARD_DEVIATION 5.2 |
| Log Premature Arterial Contractions Burden | 1.26 log(Episodes/hour) STANDARD_DEVIATION 1.35 | 1.04 log(Episodes/hour) STANDARD_DEVIATION 1.49 | 1.15 log(Episodes/hour) STANDARD_DEVIATION 1.42 |
| Premature Arterial Contractions Burden | 8.5 episode/hour STANDARD_DEVIATION 14 | 20.2 episode/hour STANDARD_DEVIATION 80 | 14.5 episode/hour STANDARD_DEVIATION 58 |
| Race/Ethnicity, Customized Race/Ethnicity Non-White | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 27 Participants | 29 Participants | 56 Participants |
| Region of Enrollment United States | 29 participants | 30 participants | 59 participants |
| Serum Magnesium Concentrations | 1.74 mEq/L STANDARD_DEVIATION 0.12 | 1.71 mEq/L STANDARD_DEVIATION 0.1 | 1.72 mEq/L STANDARD_DEVIATION 0.11 |
| Sex: Female, Male Female | 25 Participants | 18 Participants | 43 Participants |
| Sex: Female, Male Male | 4 Participants | 12 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 15 / 29 | 2 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
Change in Premature Atrial Contractions (PACs)
The primary endpoint will be the change in burden of PACs
Time frame: Change from Baseline at 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Magnesium Supplement | Change in Premature Atrial Contractions (PACs) | -0.6 Episodes/hour | Standard Deviation 7 |
| Placebo | Change in Premature Atrial Contractions (PACs) | -5.6 Episodes/hour | Standard Deviation 33 |
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.
Time frame: Baseline and week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Magnesium Supplement | Change in Magnesium Concentration | 0.07 mEq/L | Standard Deviation 0.09 |
| Placebo | Change in Magnesium Concentration | 0 mEq/L | Standard Deviation 0.1 |