EUCTR2017-004149-26-DE进行中（未招募）1 期
Effect of Metformin and Empagliflozin in insulin resistant patients with heart failure with reduced ejection fraction
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
- 88
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.Signed Written Informed Consent prior to any study related measures
- •2.Age =18 years,
- •3.Patients with Symptoms of heart failure (NYHA II-III) in stable ambulatory condition,
- •4.Patients with the diagnosis of HF 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 reduced EF (HFrEF and HFmrEF) 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 (e.g. HOMA-IR = 2.0; SPISE index < 6.87 or Quicky index < 0.32)
- •11.Willing and capable of providing informed consent, participating in all associated study activities
- •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 88
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.1.Acute decompensated heart failure reduced EF (HFrEF and HFmrEF) requiring acute intravenous therapy or acute dehydration,
- •2.Current treatment with metformin or empagliflozin
- •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 >7.5 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 <1y
- •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 (or longer) before entry into this trial (as a minimum; 5 x elimination half-life / terminal elimination of an IMP),
- •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) urine 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,
- •Exclusion criteria that occur in the course of the study do not necessarily lead to study discontinuation. Depending on the exclusion criterion, the investigator may consider interruption or discontinuation of the IMP if it occurs during the course of IMP intake.
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