Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Nov 2016
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 15, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedFebruary 24, 2023
February 1, 2023
2.3 years
November 15, 2016
February 22, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Systolic blood pressure
24 weeks
Aortic pulse wave velocity (by cardiac MRI)
24 weeks
Study Arms (2)
Magnesium
EXPERIMENTAL20 participants will be treated with 400 mg of Magnesium Oxide twice daily
Comparator
ACTIVE COMPARATOR20 participants will receive no treatment
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index greater than 30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Providence VA Medical Center
Providence, Rhode Island, 02908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Medicine at the PVAMC and Professor of Medicine at Brown University
Study Record Dates
First Submitted
November 15, 2016
First Posted
November 17, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2019
Study Completion
September 1, 2019
Last Updated
February 24, 2023
Record last verified: 2023-02