NL-OMON46516CompletedPhase 2
Randomized, double blind, placebo controlled, multicenter pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure - EMPA-RESPONSE-AHF
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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