EUCTR2017-002695-45-DE进行中（未招募）1 期
Effect of Empagliflozin on Cardiac Output in Patients with Acute Heart Failure (EMPA Acute Heart Failure) - EMPA Acute Heart Failure
RWTH Aachen University represented by the Rector, himself, represented by the Dean of the Medical Faculty0 个研究点目标入组 50 人开始时间: 2017年12月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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.Age = 18 years
- •2.Patients with acute heart failure with associated signs or
- •symptoms (dyspnea on exertion, orthopnea, paroxysmal
- •dyspnea, peripheral oedema, chest x-ray with pulmonary
- •congestion)
- •3.Serum levels of NT-proBNP = 1000 pg/ml within 48 hours of informed consent
- •4.Written informed consent prior to study participation
- •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 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1.Type 1 diabetes
- •2.Participants of child-bearing age without adequate contraception
- •3.Pregnancy or lactating females
- •4.Cardiogenic shock
- •5.Acute coronary syndrome within 30 days prior to randomization
- •6.Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
- •7.Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH = 7.30 and glucose >14 mmol/l and HCO3- = 18 mmol/l)
- •8.uncontrolled active infection
- •9. Primary cause of dyspnea due to non-cardiac, non-HF causes such as acute or chronic respiratory disorders
- •10.Coronary artery disease with planned revascularization within the study period
- •11.Renal impairment (GFR < 20 ml/min/1,73 m2)
- •12.Known hepatic impairment (as evidenced by total bilirubin >3 mg/dL) or history of cirrhosis with evidence of portal hypertension (e.g., presence of esophageal varices)
- •13.Uncontrolled thyroid disease
- •14.Uncontrolled Endocrinopathies like Graves’ disease, acromegaly,
- •Cushings’ disease
- •15.Hypertensive retinopathy or encephalopathy
- •16.Bariatric surgery in last 2 years prior to randomization
- •17.Patients in whom study participation is not deemed appropriate under consideration of clinical wellbeing by the principal investigator
- •18.The subject is mentally or legally incapacitated
- •19.The subject received an investigational drug within 30 days
- •prior to inclusion into this study
- •20.Urinary tract infections or significant formation of residual urine in medical history
- •21.Patients with particular risk for ketoacidosis (alcohol abuse, pancreatitis, pancreatic insulin deficiency from any cause, caloric restriction etc.) or ketoacidosis in the past
- •22.Frequent hypoglycaemic events (in the opinion of the investigator)
- •23.Intolerance to Empagliflozin and excipients in Empagliflozin or rather placebo
- •24. Patients with severe stenosis or regurgitation of the aortic, pulmonary or mitral valve
研究者
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