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

Sponsor
Sheba Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03840226
Collaborator
Naveh Pharma (1996) Ltd. (Other)
320
Enrollment
1
Location
2
Arms
54.2
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo Oral Tablet
  • Drug: Magnesium Oxide
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The aim of the study is to test The impact of magnum versus placebo, on six-minute and clinical outcomes of patients with CHF (level 2-4). The Primary endpoints are: Improvement in Six-Minute walk test. Improvement in clinical outcomes: death, CHF hospitalization, revascularization etc. To test the hypothesis that the six-minute results between the two study groups are different, with significance level of 5% and power of at least 80%, we use the t-test. Based on Monica et al (2001), the mean six-minute results among these patients is 218 with SD=28. for an expected difference of at least 10 meter, we need a sample size of 125 patients in each group.The aim of the study is to test The impact of magnum versus placebo, on six-minute and clinical outcomes of patients with CHF (level 2-4).The Primary endpoints are:Improvement in Six-Minute walk test. Improvement in clinical outcomes: death, CHF hospitalization, revascularization etc. To test the hypothesis that the six-minute results between the two study groups are different, with significance level of 5% and power of at least 80%, we use the t-test. Based on Monica et al (2001), the mean six-minute results among these patients is 218 with SD=28. for an expected difference of at least 10 meter, we need a sample size of 125 patients in each group.
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 25, 2019
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Magnesium

oral magnesium oxide tablets [Magnox 520 TM (magnesium oxide monohydrate, 520 mg/day of elemental magnesium), Naveh Pharma, Israel]

Drug: Magnesium Oxide
Magnesium tablets
Other Names:
  • Magnox 520 TM

    		•
    Placebo Comparator: Placebo

    Placebo tablets

    Drug: Placebo Oral Tablet
    Placebo tablets
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leviev Heart Center, Chaim Sheba Medical Center Ramat Gan Israel

    Sponsors and Collaborators

    • Sheba Medical Center
    • Naveh Pharma (1996) Ltd.

    Investigators

    • Principal Investigator: Michael Shechter, MD, Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Shechter, Director, Clinical Research Unit, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT03840226
    Other Study ID Numbers:
    • SHEBA-18-5464-MS-CTIL
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michael Shechter, Director, Clinical Research Unit, Sheba Medical Center
    magnesium
    heart failure
    Additional relevant MeSH terms:
    Heart Failure
    Magnesium Deficiency
    Magnesium Oxide

    Study Results

    No Results Posted as of May 4, 2022