The Impact of Magnesium on Exercise Tolerance, Quality of Life and Clinical Outcomes in Chronic Heart Failure Patients
- Conditions
- Magnesium DeficiencyHeart Failure
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03840226
- Lead Sponsor
- Sheba Medical Center
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
- CHF patients NYHA II-IV > 3 months
- Diuretic therapy > 3 months
- Signed informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Magnesium Magnesium Oxide oral magnesium oxide tablets \[Magnox 520 TM (magnesium oxide monohydrate, 520 mg/day of elemental magnesium), Naveh Pharma, Israel\] Placebo Placebo Oral Tablet Placebo tablets
- Primary Outcome Measures
Name Time Method Improvement in exercise duration time 1 year 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.
Qaulity of life 1 year 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.
- Secondary Outcome Measures
Name Time Method Improvment in the number of hospitalizations for heart failure 1 year 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.
Trial Locations
- Locations (1)
Leviev Heart Center, Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel