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

Heart Failure Clinical Trial

Official title:

The Impact of Magnesium Oxide Monohydrate Compared to Placebo on Exercise Tolerance, Quality of Life and Clinical Outcomes in Chronic Heart Failure Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03840226
• Other study ID #: SHEBA-18-5464-MS-CTIL
• Status: Recruiting
• Phase: Phase 3
• Start date: August 25, 2019
• Est. completion date: March 1, 2026

Study information

• Verified date: December 2023
• Source: Sheba Medical Center
• Contact: Michael Shechter, MD
• Phone: +97235302617
• Email: Michael.Shechter[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: March 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Magnesium Deficiency

Intervention

Drug:
• Placebo Oral Tablet
Placebo tablets
• Magnesium Oxide
Magnesium tablets

Locations

Country	Name	City	State
Israel	Leviev Heart Center, Chaim Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Naveh Pharma (1996) Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in exercise duration time	Improvement in 6-minute walking testing (any improvemnt of length in meters from baseline). The outcome will be measured in meters and the higher is better from baseline. A 10% higher distance from baseline will be considered significant improvement.	1 year
Primary	Qaulity of life	Improvement in quality of life by Minisota living with Heart Failure Questionnaire. The scale is in points and the higher scale the better. Any improvement in at least 10% from baseline will be considered a significant improvement.	1 year
Secondary	Improvment in the number of hospitalizations for heart failure	All hospitalizations for worsening of heart failure will be counted and recorded and the number of hospitalizations for heart failure will be conted in the magnesium compared to the placebo arms.	1 year