Effects of empagliflozin on urine output and renal function in patients with acute heart failure

Phase 1

• Conditions: acute decompensated heart failure; MedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-003692-35-DE
• Lead Sponsor: Friedrich Schiller University Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-14
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients (between 18 - 85 years) with acute decompensated heart failure (HF).
• Brain Natriuretic Peptide (BNP) >100 pg/ml, or N-terminal pro-BNP (NT-proBNP)>300 pg/ml as defined by current clinical guidelines for the diagnosis of acute decompensated HF (European Society of Cardiology 2016 HF guideline)
• Patients with diabetes mellitus type 2 or impaired glucose tolerance as defined by current clinical guidelines (German and International Diabetes Society 2016: HbA1c>6.5 % (upper limit for this clinical Trial 12%) or fasting glucose >7.0 mmol/l or any incidental glucose level >11.1 mmol/l or abnormal oral glucose tolerance test with 2h plasma glucose >7.8 mmol/l) or on antidiabetic medication or antidiabetic diet or patients with normal glucose tolerance
• Patients without cognitive impairment, i.e. they must be capable of understanding the nature, significance and implications of the clinical trial and to form a rational intention in the light of the Facts
• Written informed consent obtained
• For women with childbearing potential (until 2 years after menopause):
o Negative pregnancy test
o regular and correct use of a highly effective contraceptive method with an error rate of <1% per year (e.g. combined (estrogen and progesteron) hormonal contraception, (oral, intravaginal, transdermal), progesteron-only hormonal contraception, (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system ( IUS)) tubal ligation (female sterilization), hormon donating intrauterine device (hormonal spiral), double barrier methods, sexual abstinence, vasectomy of the partner)

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

• Type 1 diabetes mellitus
• Chronic Kidney Disease (CKD) with eGFR< 30 ml/min (if obviously not related to acute kidney injury), or end-stage renal failure with the need for chronic dialysis treatment
• Acute kidney injury (AKI) =AKIN stage 2 or requiring dialysis treatment
• Current medication with SGLT-2 inhibitors
• Known intolerance or hypersensitivity to the active substance empagliflozin, lactose or any other of the excipients listed in section 6.1. of the SmPC
• A contraindication or intolerance to furosemide
• Acute heart failure without signs of congestion (dry” patient)
•Indication for urgent coronary angiography or planned administration of a iodine based contrast agent within the next 6 days.
• Need for hemofiltration or any other form of extracorporeal therapy
• Planned surgery
• Recent participation in another clinical trial (within the last 3 months before inclusion, so that medical product/s from previous trial participation/s have been fully washed out )
• Identification of any causes of heart failure leading to decompensation that needs urgent management (like acute coronary syndrome, severe unstable arrhythmias, mechanical causes, acute pulmonary embolism)
• Incapacity to understand and / or to provide written informed consent
• Ongoing reported alcohol abuse (daily alcohol intake of more than 2 drinks (liquor, beer or wine) in men and 1 drink in women, corresponding to 12/24 g of pure alcohol per day women / men and/ or obvious alcoholisation of the patient during screening )

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of empagliflozin plus loop diuretics versus placebo plus loop diuretics in patients with ADHF on the increase of urine output ;Secondary Objective: To evaluate the effects of empagliflozin plus loop diuretics versus placebo plus loop diuretics in patients with ADHF, in terms of renal function, length of hospital stay, quality of life, insulin resistance and the need for further administration of diuretics;Primary end point(s): Total urine output as measured by daily volume summed up over 5 days ;Timepoint(s) of evaluation of this end point: after 5 days of therapy with Empaglifozin