Effects of Magnesium orotate in patients with heartfailure with decreased ejection fraction on NTproBNP - a prospective, monocentric, randomized, double blind Placebo-controlled cross-over study

Phase 2

• Conditions: I50; Heart failure

• Registration Number: DRKS00014829
• Lead Sponsor: WÖRWAG Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-05
• Study Completion: 2023-09-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male or female patients = 18 years
2. Patients with chronic heart failure who have been treated continuously for at least 3 months according to current guidelines
3. NYHA Class II-IV
4. LVEF < 45%
5. NTproBNP >= 600 pg / ml (most recent value in the last 3 months)
6. Willingness to abstain from consuming alcohol during the study period
7. Existence of written consent

Exclusion Criteria

1. LVEF = 45%
2. NTproBNP < 600 pg / ml
3. Known hypersensitivity to magnesium or any of the other ingredients
of the test medication
4. Currently decompensated heart failure
5. Severe renal impairment
6. GFR <30 ml / min / 1.73 m2
7. Acute coronary syndrome in the last 3 months before inclusion
8. Myasthenia gravis
9. Known AV block grade 2 or 3
10. Existing or planned pregnancy or women who breastfeed
11. Myocarditis, valvular cardiomyopathy, Tako-Tsubo cardiomyopathy, or peripartum cardiomyopathy
12. Patients who had an organ transplant
13. Patients who have a LVAD
14. Hb <8 g / dl
15. AST / ALT> 3 x ULN
16. Stroke / TIA in the last 3 months
17. Heart failure in the last 3 months
18. Cancer disease or treatment in the last 5 years
19. Tuberculosis, hepatitis, HIV infection or other serious viral diseases
20. Depressive illnesses with suicidal thoughts or suicide attempt (s) in the anamnesis
21. Severe mitral or aortic valve disease
22. Existence of diseases with a life expectancy <1 year
23. Any clinical finding which, in the opinion of the investigator, affects participation in the study
24. Dependency relationship with the sponsor or the study staff
25. Simultaneous participation in other clinical trials or registries
26. Ingestion of magnesium orotate in the past 12 months
27. Ingestion of other magnesium compounds in the last 4 weeks
28. Patients who are not expected to adhere to the guidelines in the study protocol (lack of compliance)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects of Magnesiumorotate-dihydrate on NTproBNP after 12 weeks in comparison to placebo

Secondary Outcome Measures

Name	Time	Method
Effects on the following Parameter after 12 weeks in comparision to Placebo:<br>- Symptoms of Heartinsufficience<br>- NYHA-classification<br>- LVEF<br>- KCCG-questionnaire<br>- Hospitalisation rate<br>- EQ-5D-5L<br><br>Safety:<br>- AE/ SAE<br>- Routine blood parameters<br>