Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

Not Applicable

Completed

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

• Registration Number: NCT02966912
• Lead Sponsor: Providence VA Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Primary Completion: 2019-03
• Study Completion: 2019-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium	400 mg of Magnesium Oxide twice daily for 24 weeks	20 participants will be treated with 400 mg of Magnesium Oxide twice daily
Comparator	Open label (none)	20 participants will receive no treatment

Primary Outcome Measures

Name	Time	Method
Left ventricular myocardial triglyceride content (by cardiac MRI)	24 weeks
Left ventricular extracellular volume fraction (by cardiac MRI)	24 weeks
Left ventricular mass (by cardiac MRI)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure	24 weeks
Aortic pulse wave velocity (by cardiac MRI)	24 weeks

Trial Locations

Locations (1)

Providence VA Medical Center; 🇺🇸 Providence, Rhode Island, United States