Heart failure with reduced ejection fraction MedDRA version: 20.0 Level: LLT Classification code 10019284 Term: Heart failure, congestive System Organ Class: 100000004849 MedDRA version: 20.1 Level: LLT Classification code 10064081 Term: Heart failure NYHA class III System Organ Class: 100000004849 MedDRA version: 20.1 Level: LLT Classification code 10064080 Term: Heart failure NYHA class II System Organ Class: 100000004849 MedDRA version: 20.1 Level: LLT Classification code 10064082 Term: H
Conditions
Interventions
Trade Name: Magnerot Classic N
Product Name: Magnesiumorotat-Dihydrate
Pharmaceutical Form: Tablet
INN or Proposed INN: MAGNESIUM OROTATE-DIHYDRATE
CAS Number: 34717-03-8
Other descriptive name: MAGNE
Sponsors
WÖRWAG Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 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
Exclusion criteria: 1. LVEF = 45% 2. NTproBNP 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • Improve the symptoms of heart failure (weight, edema) • Improve the NYHA classification • Increase in LVEF • Improvement of symptoms as measured by the KCCQ questionnaire (Faller et al., 2005) • Reduction of hospitalization rate due to cardiac insufficiency, cardiac decompensation or myocardial infarction • 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
| Measure | Time frame |
|---|---|
| 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) NYHA-classification: Baseline, Week 4, Week 12, Week 20, Week 24, Week 32 (EoS) | — |
Countries
Germany
Contacts
Public ContactProject manager
WÖRWAG Pharma GmbH & Co. KG
Outcome results
None listed