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

NCT ID: NCT03840226

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-25

Study Completion Date

2026-03-01

Brief Summary

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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

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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.

Conditions

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Magnesium Deficiency Heart Failure

Keywords

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magnesium heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Magnesium

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

Group Type ACTIVE_COMPARATOR

Magnesium Oxide

Intervention Type DRUG

Magnesium tablets

Placebo

Placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo tablets

Interventions

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Placebo Oral Tablet

Placebo tablets

Intervention Type DRUG

Magnesium Oxide

Magnesium tablets

Intervention Type DRUG

Other Intervention Names

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Placebo Magnox 520 TM

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Naveh Pharma (1996) Ltd.

UNKNOWN

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Michael Shechter

Director, Clinical Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Shechter, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Leviev Heart Center, Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Michael Shechter, MD

Role: CONTACT

Phone: +97235302617

Email: [email protected]

Nava Eizenberg, RN

Role: CONTACT

Phone: +97235302617

Email: [email protected]

Facility Contacts

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Michael Shechter, MD

Role: primary

Other Identifiers

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SHEBA-18-5464-MS-CTIL

Identifier Type: -

Identifier Source: org_study_id