EUCTR2017-001679-22-NLActive, not recruitingPhase 1
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
niveristy Medical Center Groningen0 sites80 target enrollmentStarted: September 7, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Exclusion Criteria
- •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.
Investigators
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