The Impact of Magnesium on Exercise Tolerance, Quality of Life and Clinical Outcomes in Chronic Heart Failure Patients

Sheba Medical Center

Status and phase: Enrolling; Phase 3

Conditions: Magnesium Deficiency; Heart Failure

Treatments: Drug: Placebo Oral Tablet; Drug: Magnesium Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT03840226

SHEBA-18-5464-MS-CTIL

Details and patient eligibility

About

Magnesium supplementation could improve cardiac performance. Patients with chronic heart failure (CHF) are magnesium deficient and we hypothesized that 1 year supplementation of oral magnesium comparted to placebo will improve exercise duration time and quality of life.

Full description

Magnesium supplementation improves myocardial metabolism, inhibits calcium accumulation and myocardial cell death; it improves vascular tone, peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free radicals, improves human endothelial function and inhibits platelet function. Patients with chronic heart failure (CHF) are magnesium deficient. The activation of the renin-angiotensin-aldosterone system and the use of diuretics are associated with depletion of potassium and magnesium in CHF. Magnesium deficiency stimulates aldosterone production and secretion, while magnesium infusion decreases aldosterone production production by inhibiting cellular calcium influx. Adamopoulos et al recently found that CHF in patients [mainly New York Heart Association (NYHA) II-II] with low serum magnesium ≤ 2 mEq/L was associated with increased cardiovascular mortality (but had no association with cardiovascular hospitalization) compared to those with serum magnesium > 2 mEq/L in a long-term follow-up of 36 months, suggesting that most of these deaths were likely sudden (arrhythmic) in nature.

Furthermore, Stepura and Martynow demonstrated that oral magnesium orotate used as adjuvant therapy in severe NYHA IV CHF patients increased 1-year survival rate and improved clinical symptoms and patient's quality of life compared to placebo. The investigators hypothesized that 1-year supplementation of oral magnesium compared to placebo to CHF patients will improve exercise duration time and quality of life.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups, including a placebo group

Magnesium

Active Comparator group

Description:

oral magnesium oxide tablets \[Magnox 520 TM (magnesium oxide monohydrate, 520 mg/day of elemental magnesium), Naveh Pharma, Israel\]

Treatment:

Drug: Magnesium Oxide

Placebo

Placebo Comparator group

Description:

Placebo tablets

Treatment:

Drug: Placebo Oral Tablet