Randomized, double blind, placebo controlled study on the effect of the SGLT2 inhibitor (a new class of anti-diabetics with diuretic effects) Empagliflozin in patients admitted with acute decompensated heart failure
- Conditions
- Acute (decompensated) heart failureMedDRA version: 20.0Level: HLGTClassification code 10019280Term: Heart failuresSystem Organ Class: 100000004849MedDRA version: 20.0Level: HLTClassification code 10019283Term: Heart failure signs and symptomsSystem Organ Class: 100000004908MedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000011689Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-001679-22-NL
- Lead Sponsor
- niveristy Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
1. Male or female >18 years of age;
2. Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
a. Dyspnea at rest or with minimal exertion
b. Signs of congestion, such as edema, rales, and/or congestion on chest radiograph
c. BNP =350 pg/mL or NT-proBNP =1,400 pg/mL (for patients with AF: BNP=500 pg/mL or NT-proBNP =2,000 pg/mL)
d. Treated with loop diuretics at screening
3. Able to be randomized within 24 hours from presentation to the hospital
4. Able and willing to provide freely given written informed consent
5. eGFR (CKD-EPI) =30 ml/min/1.73m2 between presentation and randomization
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1. Dyspnea primarily due to non-cardiac causes
2. Cardiogenic shock
3. Acute coronary syndrome within 30 days prior to randomization
4. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
3. Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L)
4. Pregnant or nursing (lactating) women
5. Current participation in any interventional study
6. Inability to follow instructions or comply with follow-up procedures
7. Any other medical conditions that may put the patient at risk or influence study results in the investigator’s opinion, or that the investigator deems unsuitable for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this trial is to evaluate whether empagliflozin 10mg/day will relieve dyspnea, improves diuretic response, decreases length of initial hospital stay and NT-proBNP compared to placebo during hospital admission for acute decompensated heart failure.;Secondary Objective: The secondary objectives of this trial are to evaluate the effects of empagliflozin on change in dyspnea, renal function, and NT-proBNP and on 30-day death and/or heart failure hospital.;Primary end point(s): a) Dyspnea relief, assessed by VAS at baseline to day 4 (or discharge if earlier); <br>b) Diuretic response (defined as ? weight kg/[(total i.v. dose)/40mg]+[(total oral dose)/80mg)] furosemide (or equivalent loop diuretic dose) up to day 4<br>c) Length of initial hospital stay; <br>d) Change in NT-proBNP from baseline to day 4 (or discharge if earlier);Timepoint(s) of evaluation of this end point: 4 days and inhospital stay (variable)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Death and/or heart failure re-admission at day 30<br>Change in plasma values of renal function, including creatinine, eGFR, cystatin C, BUN, renal biomarkers and hemoglobin, hematocrit, albumin from baseline to day 4 (or discharge if earlier) or day 30<br>Change in urinary renal biomarkers to day 4 o day 30<br>Adverse events to 60 days;Timepoint(s) of evaluation of this end point: day 4 and day 30