EMPA Acute Heart Failure

NCT ID: NCT03554200

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2020-10-29

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.

Conditions

Diabetes Mellitus, Type 2; Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Empagliflozin

Patients will receive empagliflozin 10 mg qd for a period of 30 days.

Group Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

Standard of Care + Empagliflozin: 10 mg (tablets) once daily

Placebo

Patients of the placebo arm will receive placebo tablets qd for a period of 30 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Standard of Care + Placebo: Matching Placebo (tablets) once daily

Interventions

Empagliflozin

Standard of Care + Empagliflozin: 10 mg (tablets) once daily

Intervention Type: DRUG

Placebo

Standard of Care + Placebo: Matching Placebo (tablets) once daily

Intervention Type: DRUG

Other Intervention Names

Jardiance

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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. Signs of uncontrolled active infection

9. Dyspnea due to non-cardiac causes (severe pulmonary disease, anemia, severe obesity), non-HF causes such as acute or chronic respiratory disorders

10. Coronary artery disease with requirement for 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. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Internal Medicine I RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2017-002695-45

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15-156

Identifier Type: -

Identifier Source: org_study_id