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

Last updated: December 10, 2023
Sponsor: Sheba Medical Center
Overall Status: Active - Recruiting

Phase

3

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Placebo Oral Tablet

Magnesium Oxide

Clinical Study ID

NCT03840226
SHEBA-18-5464-MS-CTIL
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CHF patients NYHA II-IV > 3 months
  • Diuretic therapy > 3 months
  • Signed informed consent

Exclusion

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 fromrandomization
  • Any malignancy with life expectancy < 1 year Any AV Block> 2 degree without apacemaker

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: Placebo Oral Tablet
Phase: 3
Study Start date:
August 25, 2019
Estimated Completion Date:
March 01, 2026

Study 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.

Connect with a study center

  • Leviev Heart Center, Chaim Sheba Medical Center

    Ramat Gan,
    Israel

    Active - Recruiting

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