Status:
RECRUITING
The Impact of Magnesium on Exercise Tolerance, Quality of Life and Clinical Outcomes in Chronic Heart Failure Patients
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Naveh Pharma (1996) Ltd.
Conditions:
Magnesium Deficiency
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 compart...
Detailed Description
Magnesium supplementation improves myocardial metabolism, inhibits calcium accumulation and myocardial cell death; it improves vascular tone, peripheral vascular resistance, afterload and cardiac outp...
Eligibility Criteria
Inclusion
- CHF patients NYHA II-IV \> 3 months
- Diuretic therapy \> 3 months
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03840226
Start Date
August 25 2019
End Date
March 1 2026
Last Update
December 12 2023
Active Locations (1)
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1
Leviev Heart Center, Chaim Sheba Medical Center
Ramat Gan, Israel