DRKS00013928招募中2 期
Effect of Metformin and Empaglifozin in insulin resistant patients with heart failure with reduced ejection fraction - METRIS-HF (EMPA) DZHK18
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Signed Written Informed Consent
- •2. Age =18 years,
- •3. Patients with clinical signs of heart failure (NYHA II-III) in stable ambulatory condition,
- •4. Patients with the diagnosis of HFrEF for >6 months,
- •5. Left ventricular ejection fraction (LVEF) =50%,
- •6. 6-minute walking distance of <450m,
- •7. Elevated natriuretic peptides (BNP =100pg/mL or N-terminal-pro-BNP =300 pg/mL),
- •8. Current standard medication for HFrEF therapy according to guideline recommendations in individually optimized doses,
- •9. Patients need to be free of signs of acute decompensated HF, but can be recruited at the end of a hospital stay, if clinically stabilised,
- •10. Presence of insulin resistance (HOMA-IR >2.0; Spise index <6.87; Quicky index < 0.32)
- •11. Willing and capable of providing informed consent, participating in all associated study activities
排除标准
- •1. Acute decompensation of HF or acute dehydration,
- •2. current treatment with metformin
- •3. known hypersensitivity or contraindication for Metformin or to any of the excipients of the Investigational Medicinal Product (IMP) or placebo
- •4. Type I DM
- •5. Diagnosed DM (HbA1c > 7.0 or existing medical treatment for DM)
- •6. Clinical signs or symptoms of dehydration requiring iv volume therapy,
- •7. impaired kidney function > CKD stage III (GFR < 30 ml/min/1.73m2)
- •8. Acute infection requiring antibiotic therapy
- •9. Any clinical condition that limits the life expectancy < 1 year
- •10. incapability to participate in the trial
- •11. Acute systemic illness, malignancy, inflammatory disease, requiring, antibiotic therapy, immune-suppressive - or steroid therapy
- •12. Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial
- •13. Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial
- •14. Subjects who are legally detained in an official institution
- •15. Subjects who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
- •16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
- •17. For female patients of reproductive potential: Unwilling to agree to use a highly effective method of contraception (Pearl index < 1) throughout the study period
研究者
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