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

NCT03840226 | Recruiting Phase 3

• 1 other identifier: SHEBA-18-5464-MS-CTIL
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnesium Deficiency; Heart Failure

Keywords

magnesium; heart failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Improvment in the number of hospitalizations for heart failure

  1 year

Study Arms (2)

Magnesium

ACTIVE COMPARATOR

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

Drug: Magnesium Oxide

Placebo

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo Oral Tablet

Interventions

Placebo Oral Tablet DRUG

Placebo tablets

Also known as: Placebo

Placebo

Magnesium Oxide DRUG

Magnesium tablets

Also known as: Magnox 520 TM

Magnesium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CHF patients NYHA II-IV \> 3 months
• Diuretic therapy \> 3 months
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Naveh Pharma (1996) Ltd.: collaborator

Study Sites (1)

Leviev Heart Center, Chaim Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Magnesium Deficiency; Heart Failure

Interventions

Magnesium Oxide

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Michael Shechter, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Shechter, MD

CONTACT

+97235302617; Michael.Shechter@sheba.health.gov.il

Nava Eizenberg, RN

CONTACT

+97235302617; Nava.Eizenberg@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research Unit

Model Details: 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: 1. Improvement in Six-Minute walk test. 2. 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.

Study Record Dates

• First Submitted: February 9, 2019
• First Posted: February 15, 2019
• Study Start: August 25, 2019
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

IL (1)