Overview

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

Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sheba Medical Center
Collaborator:
Naveh Pharma (1996) Ltd.
Treatments:
Magnesium Oxide
Criteria
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