Effect of Empagliflozin on Cardiac Output in Patients With Acute Heart Failure (EMPA Acute Heart Failure)
Overview
- Phase
- Phase 2
- Intervention
- Empagliflozin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- RWTH Aachen University
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Empagliflozin
Patients will receive empagliflozin 10 mg qd for a period of 30 days.
Intervention: Empagliflozin
Placebo
Patients of the placebo arm will receive placebo tablets qd for a period of 30 days.
Intervention: Placebo
Outcomes
Primary Outcomes
effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure
Time Frame: 30 days
by ClearSight System
Secondary Outcomes
- 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)