Effect of Empagliflozin on Cardiac Output in Patients With Acute Heart Failure (EMPA Acute Heart Failure)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure
研究概览
简要总结
In this study the investigators are aiming to treat patients with acute heart failure with or without diabetes with Empagliflozin or placebo. Given the beneficial effects of Empagliflozin on heart failure hospitalization in the EMPA-REG OUTCOME trial, the investigators do expect a similar beneficial effect to be present in patients with acute heart failure. Acute heart failure is a state of hydropic decompensation resulting in dyspnea and congestions, caused by different etiologies of cardiac disease. Recompensation is reached by application of diuretic drugs and fluid restriction.
详细描述
In the present study patients will be randomized into 2 groups (standard of care + Empagliflozin 10 mg/d or standard of care + placebo). Cardiac output will be assessed by a medical device for noninvasive monitoring of hemodynamic parameters (cardiac output, systemic vascular resistance, stroke volume and blood pressure) using finger cuff technology for pulse contour analysis.
These investigations will inform about Empagliflozin dependent effects on hemodynamic and cardiac function in patients with acute heart failure. The investigation will further assess the therapeutic efficacy of Empagliflozin on heart failure symptoms using objective (respiratory rate, oxygen requirement, peak expiratory flow rate, urinary volume, body weight, diuretic requirement, length of hospital stay) and well accepted, patient orientated secondary endpoints. In addition, metabolic regulators and parameters relevant for cardiac function and substrate metabolism will be assessed to further investigate possible mechanisms of Empagliflozin-dependent actions on cardiac function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This trial is double-blinded. After randomization neither the patients nor the investigator will be aware of the treatment allocation. Patients assigned to one of the double-blinded treatment will take one tablet Empagliflozin or matching placebo. The tablets will be identical in appearance.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients with acute heart failure with associated signs or symptoms (dyspnea on exertion, orthopnea, paroxysmal dyspnea, peripheral oedema, chest x-ray with pulmonary congestion)
- •Serum levels of NT-proBNP ≥ 1000 pg/ml within 48 hours of Informed Consent
- •Written informed consent prior to study participation
排除标准
- •Type 1 diabetes
- •Participants of child-bearing age without adequate contraception
- •Pregnancy or lactating females
- •Cardiogenic shock
- •Acute coronary syndrome within 30 days prior to randomization
- •Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
- •Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH ≤ 7.30 and glucose >14 mmol/l and HCO3- ≤ 18 mmol/l)
- •Signs of uncontrolled active infection
- •Dyspnea due to non-cardiac causes (severe pulmonary disease, anemia, severe obesity), non-HF causes such as acute or chronic respiratory disorders
- •Coronary artery disease with requirement for revascularization within the study period
- •Renal impairment (GFR < 20 ml/min/1,73 m2)
- •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)
- •Uncontrolled thyroid disease
- •Endocrinopathies like Graves' disease, acromegaly, Cushings' disease
- •Hypertensive retinopathy or encephalopathy
- •Bariatric surgery in last 2 years prior to randomization
- •Patients in whom study participation is not deemed appropriate under consideration of clinical wellbeing by the principal investigator
- •The subject is mentally or legally incapacitated
- •The subject received an investigational drug within 30 days prior to inclusion into this study
- •Urinary tract infections or significant formation of residual urine in medical history
- •Patients with particular risk for ketoacidosis (alcohol abuse, pancreatitis, pancreatic insulin deficiency from any cause, caloric restriction etc.) or ketoacidosis in the past
- •Frequent hypoglycaemic events (in the opinion of the investigator)
- •Intolerance to Empagliflozin and excipients in Empagliflozin or rather placebo
- •Patients with severe stenosis or regurgitation of the aortic, pulmonary or mitral valve
研究组 & 干预措施
Empagliflozin
Patients will receive empagliflozin 10 mg qd for a period of 30 days.
干预措施: Empagliflozin (Drug)
Placebo
Patients of the placebo arm will receive placebo tablets qd for a period of 30 days.
干预措施: Placebo (Drug)
结局指标
主要结局
effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure
时间窗: 30 days
by ClearSight System
次要结局
- Cardio vascular(30 days)
- change of microbiome(30 days)
- Hemodynamics(30 days)
- Exercise Capacity(30 days)
- Blood(30 days)
- Clinical judged diuretic requirement(30 days)
- Effect of Empagliflozin 10 mg daily on Left ventricular systolic function(30 days)
- Diuretic response(30 days)
- Patient-reported dyspnea(30 days)
- Effect of Empagliflozin on systemic quality of life(30 days)
- Effect of Empagliflozin on hospitalization due to cardiovascular causes or readmission for heart failure or renal failure(30 days)
- Effect of Empagliflozin on death due to cardiovascular causes(30 days)
- Urine(30 days)
- Body weight(30 days)
- Respiratory rate(30 days)
- Kidney injury risk score(30 days)
- Peak expiratory flow rate(30 days)
- Oxygen(30 days)
- Effect of Empagliflozin 10 mg daily on Left ventricular diastolic function(30 days)