Magnesium DeficiencyPhase 3NCT03840226
The Impact of Magnesium on Exercise Tolerance, Quality of Life and Clinical Outcomes in Chronic Heart Failure Patients
A Phase 3 study testing Magnesium Oxide in people with Magnesium Deficiency and Heart Failure, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Magnesium Deficiency, Heart Failure
- What is being tested?
- Magnesium Oxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Aug 2019to 1 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CHF patients NYHA II-IV > 3 months
- Diuretic therapy > 3 months
- Signed informed consent
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Leviev Heart Center, Chaim Sheba Medical Center
Ramat Gan
Michael Shechter, MD, +97235302617, Michael.Shechter@sheba.health.gov.il
About this study
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
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.
Read the 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.
- Conditions
- Magnesium Deficiency, Heart Failure
- Being tested
- Placebo Oral Tablet, Magnesium Oxide
- Keywords
- magnesium, heart failure
- Medical subject headings
- Magnesium Deficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral TabletDrug
Also called Placebo
Placebo tablets
Magnesium OxideDrug
Also called Magnox 520 TM
Magnesium tablets
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Active comparator | oral magnesium oxide tablets [Magnox 520 TM (magnesium oxide monohydrate, 520 mg/day of elemental magnesium), Naveh Pharma, Israel] Receives: Drug: Magnesium Oxide |
| Placebo | Placebo comparator | Placebo tablets Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
Improvment in the number of hospitalizations for heart failure
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Aug 2019
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium DeficiencyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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: 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Naveh Pharma (1996) Ltd.
- Responsible party
- Principal investigator, Michael Shechter, Sheba Medical Center
- Investigators
- Michael Shechter, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840226
- Sponsor's protocol ID
- SHEBA-18-5464-MS-CTIL
- Status last verified
- Dec 2023
- First submitted
- 9 Feb 2019
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03840226
- Acronym / sponsor ID
- SHEBA-18-5464-MS-CTIL
- Conditions
- Magnesium Deficiency, Heart Failure
- Keywords
- magnesium, heart failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Naveh Pharma (1996) Ltd.
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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: 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.
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Active comparator | Drug: Magnesium Oxideoral magnesium oxide tablets [Magnox 520 TM (magnesium oxide monohydrate, 520 mg/day of elemental magnesium), Naveh Pharma, Israel] |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CHF patients NYHA II-IV > 3 months
- Diuretic therapy > 3 months
- Signed informed consent
Key exclusion criteria (13 listed)
- chronic renal failure (serum creatinine > 3 mg/dL)
- AMI/ACS< 3 months from randomization
- Cardiac or other organ transplantation
- Uncontrolled hypo/hyperthyroidism
- Chronic diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Oral TabletAlso: PlaceboPlacebo tablets | Drug | Placebo |
| Magnesium OxideAlso: Magnox 520 TMMagnesium tablets | Drug | Magnesium |
Primary outcome
Improvement in exercise duration time
Time frame: 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.
Qaulity of life
Time frame: 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.
1 secondary outcome
Improvment in the number of hospitalizations for heart failure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Shechter, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium Oxide in people with Magnesium Deficiency and Heart Failure, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Shechter, MD (+97235302617, Michael.Shechter@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in exercise duration time (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.