Investigation of effects of Magnesium orotate on cardiac marker in patients with severe congestive heart failure.

Phase 1

• Conditions: Heart failure with reduced ejection fraction; MedDRA version: 20.0Level: LLTClassification code 10019284Term: Heart failure, congestiveSystem Organ Class: 100000004849; MedDRA version: 20.1Level: LLTClassification code 10064081Term: Heart failure NYHA class IIISystem Organ Class: 100000004849; MedDRA version: 20.1Level: LLTClassification code 10064080Term: Heart failure NYHA class IISystem Organ Class: 100000004849; MedDRA version: 20.1Level: LLTClassification code 10064082Term: Heart failure NYHA class IVSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004600-53-DE
• Lead Sponsor: WÖRWAG Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-19
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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. Patients who had an organ transplant
12. Patients who have a LVAD
13. Hb <8 g /dl
14. AST / ALT> 3 x ULN
15. Stroke / TIA in the last 3 months
16. Heart failure in the last 3 months
17. Cancer disease or treatment in the last 5 years
18. Tuberculosis, hepatitis, HIV infection or other serious viral diseases
19. Depressive illnesses with suicidal thoughts or suicide attempt (s) in the anamnesis
20. Severe mitral or aortic valve disease
21.Myocarditis, valvular cardiomyopathy, Tako-Tsubo-cardiomyopathy or peripartal cardiomyopathy
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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to show that a significant reduction of NTproBNP can be achieved by the regular intake of magnesium orotate compared to placebo.;Secondary Objective: In addition, it is to be shown that magnesium orotate is superior to placebo over<br>• Improve the symptoms of heart failure (weight, edema)<br>• Improve the NYHA classification<br>• Increase in LVEF<br>• Improvement of symptoms as measured by the KCCQ questionnaire (Faller et al., 2005)<br>• Reduction of hospitalization rate due to cardiac insufficiency, cardiac decompensation or myocardial infarction<br>• Improve the patient's subjective quality of life as measured by EQ-5D-5L;Primary end point(s): Measurement of NTproBNP;Timepoint(s) of evaluation of this end point: Baseline, Week 4, Week 12, Week 20, Week 24, Week 32 (EoS)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Patient questionnaires, NYHA-classification, echocardiogram;Timepoint(s) of evaluation of this end point: Patient questionnaires and echocardiogram: Baseline, Week 12, Week 20, Week 32 (EoS)<br>NYHA-classification: Baseline, Week 4, Week 12, Week 20, Week 24, Week 32 (EoS)