Magnesium supplementation for improving heart failure outcomes
The Impact of Magnesium Oxide Monohydrate Compared to Placebo on Exercise Tolerance, Quality of Life and Clinical Outcomes in Chronic Heart Failure Patients
This study is testing if taking magnesium supplements can help people with chronic heart failure feel better and improve their heart health compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT03840226 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of oral magnesium supplementation on exercise tolerance, quality of life, and clinical outcomes in patients with chronic heart failure (CHF). The study compares magnesium oxide to a placebo over a one-year period, focusing on patients who are magnesium deficient. The hypothesis is that magnesium will enhance cardiac performance and reduce cardiovascular mortality associated with low serum magnesium levels. The trial includes patients with New York Heart Association (NYHA) functional classes II to IV who have been on diuretic therapy for at least three months.
Who should consider this trial
Good fit: Ideal candidates are patients with chronic heart failure classified as NYHA II to IV who have been on diuretic therapy for more than three months.
Not a fit: Patients with chronic renal failure, recent acute myocardial infarction, or uncontrolled arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise capacity and quality of life for patients with chronic heart failure.
How similar studies have performed: Previous studies have shown promising results with magnesium supplementation in heart failure patients, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CHF patients NYHA II-IV \> 3 months * Diuretic therapy \> 3 months * Signed informed consent Exclusion Criteria: * chronic renal failure (serum creatinine \> 3 mg/dL) * AMI/ACS\< 3 months from randomization * Cardiac or other organ transplantation * Uncontrolled hypo/hyperthyroidism * Chronic diarrhea * Life expectancy \< 1 year * Known psychiatric disease which inhibits patient's enrollment to the study * Inability to come for follow-up visits * Any planned operation/invasive procedures in the near 6 months * Uncontrolled cardiac arrhythmias * Inability to perform 6 minute walk testing * Any participation in another interventional clinical trial \< 1 month from randomization * Any malignancy with life expectancy \< 1 year Any AV Block\> 2 degree without a pacemaker
Where this trial is running
Ramat Gan
- Leviev Heart Center, Chaim Sheba Medical Center — Ramat Gan, Israel (Recruiting)
Study contacts
- Principal investigator: Michael Shechter, MD — Sheba Medical Center
- Study coordinator: Michael Shechter, MD
- Email: Michael.Shechter@sheba.health.gov.il
- Phone: +97235302617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.