Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

Providence VA Medical Center

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: 400 mg of Magnesium Oxide twice daily for 24 weeks; Other: Open label (none)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02966912

442702

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Body mass index greater than 30 kg/m2

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Magnesium

Experimental group

Description:

20 participants will be treated with 400 mg of Magnesium Oxide twice daily

Treatment:

Dietary Supplement: 400 mg of Magnesium Oxide twice daily for 24 weeks

Comparator

Active Comparator group

Description:

20 participants will receive no treatment

Treatment:

Other: Open label (none)