EUCTR2016-004600-53-DE进行中（未招募）1 期
MACH 2 - Magnesium orotate in severe congestive heart failure - Part 2 - MACH2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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