Effect of Empagliflozin on Cardiac Output in Patients with Acute Heart Failure (EMPA Acute Heart Failure)

Phase 1

• Conditions: Patients with acute heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002695-45-DE
• Lead Sponsor: RWTH Aachen University represented by the Rector, himself, represented by the Dean of the Medical Faculty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-22
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

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

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.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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine the effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure. ;Secondary Objective: Effect of Empagliflozin on systemic vascular resistance, stroke volume, left ventricular systolic and diastolic function, exercise capacity, patient-reported dyspnea, peak expiratory flow rate, clinical judged diuretic requirement, heart rate variability, percentage of supraventricular and ventricular contraction of total heart beats, NT-proBNP, eGFR, cystatin c, kidney injury risk score (defined by TIMP-2 x IGFBP7), sodium excretion and metabolic parameters (glucagon, insulin, total-ketone bodies, -hydroxybutyrate, etc.) in patients with acute heart failure;Primary end point(s): Effect of Empagliflozin 10 mg once daily on cardiac output by ClearSight System in comparison to placebo ;Timepoint(s) of evaluation of this end point: Baseline and 6 hours, day 1, 3, 7 and 30 following treatment initiation