Randomized, double blind, placebo controlled, multicenter pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure
- Conditions
- 'Acute Heart Failure'10082206
- Registration Number
- NL-OMON46516
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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
1. Diabetes Mellitus Type I
2. Dyspnea primarily due to non-cardiac causes
3. Cardiogenic shock
4. Acute coronary syndrome within 30 days prior to randomization
5. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to
randomization
6. Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L)
7. Pregnant or nursing (lactating) women
8. Current participation in any interventional study
9. Inability to follow instructions or comply with follow-up procedures
10. 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>a) Dyspnea relief, assessed by VAS at baseline to day 4 (or discharge if<br /><br>earlier);<br /><br>b) Diuretic response (defined as * weight kg/[(total i.v. dose)/40mg]+[(total<br /><br>oral dose)/80mg)] furosemide (or equivalent loop diuretic dose) up to day 4) c)<br /><br>Length of initial hospital stay;<br /><br>d) Change in NT-proBNP from baseline to day 4 (or discharge if earlier)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Death and/or heart failure re-admission through day 60<br /><br>Change in plasma values of renal function, including creatinine, eGFR,<br /><br>cystatin C, BUN, renal biomarkers and hemoglobin, hematocrit, albumin from<br /><br>baseline to day 4 (or discharge if earlier) or day 30<br /><br>Change in urinary renal biomarkers to day 4 or day 30</p><br>