Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

Study Overview
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Brief Summary
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The objective of this study is to investigate whether nutritional supplementation with magnesium can improve cardiovascular structure and function in participants with obesity - with a long-term goal of preventing clinical heart failure. Specifically, in a randomized open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.

Detailed Description
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The investigators propose a 24-week therapeutic trial involving 40 participants with obesity from the Providence VA Medical Center without clinical heart failure. 20 participants will be treated with 400 mg of Magnesium Oxide twice daily, while 20 participants will receive no treatment. The trial tests the hypothesis that oral Mg supplementation will improve: LV structure (by LV mass, steatosis, and ECV), LV function (systolic and diastolic), vascular health (systolic blood pressure and aortic pulse wave velocity) and visceral adiposity.

Official Title
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Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: 400 mg of Magnesium Oxide twice daily for 24 weeks
* Other: Open label (none)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index greater than 30 kg/m2 Exclusion Criteria: History of hospitalization for heart failure (systolic or diastolic); Unstable angina or prior myocardial infarction; LV ejection fraction <50% on imaging study; Valvular heart disease (stenosis or insufficiency) greater than moderate degree; Renal dysfunction, serum creatinine >2.5 mg/dL or estimated creatinine clearance <30 mL/min/1.73 m2 (30), Pregnant women or actively breastfeeding women History of drug supplementation within the last 6 months in which more than 50 miliequivalents per day of supplemental magnesium is contained

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium<br>20 participants will be treated with 400 mg of Magnesium Oxide twice daily | Dietary Supplement: 400 mg of Magnesium Oxide twice daily for 24 weeks<br> <br> |
| Active Comparator: Comparator<br>20 participants will receive no treatment | Other: Open label (none)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular mass (by cardiac MRI) |  | 24 weeks | 
| Left ventricular myocardial triglyceride content (by cardiac MRI) |  | 24 weeks | 
| Left ventricular extracellular volume fraction (by cardiac MRI) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure |  | 24 weeks | 
| Aortic pulse wave velocity (by cardiac MRI) |  | 24 weeks |