Phase 2
N=80
Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure
Heart Failure Acute · Heart Failure，Congestive · Heart Failure; With Decompensation
Bottom Line
View on ClinicalTrials.gov: NCT03200860 ↗Enrolled (actual)
80
Serious AEs
22.8%
Results posted
Feb 2020
Primary outcome: Primary: Dyspnea — 1264; 1650 mmxh — p=0.18
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Empagliflozin 10 MG (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Medical Center Groningen
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dyspnea |
1264; 1650 | 0.18 |
| PRIMARY Diuretic Response |
-0.35; -0.12 | 0.37 |
| PRIMARY Length of Stay |
8; 8 | 0.58 |
| PRIMARY Plasma NTproBNP |
-46; -42 | 0.63 |
| SECONDARY Death and/or Heart Failure Re-admission |
3; 6 | 0.31 |
| SECONDARY Inhospital Worsening Heart Failure, All Cause Mortality or Heart Failure Readmission at Day 60 |
4; 13 | 0.014 sig |
| SECONDARY All Cause Mortality |
1; 3 | — |
Summary
Acute decompensated heart failure is the fastest growing disease in the world and the leading cause of hospital admissions worldwide. Short term mortality and rehospitalization are extremely high (20-30% within 3-6 months) and there is no therapy available that improves clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose co-transporter with diuretic and renal- protective properties. In patients with type 2 diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of hospitalization for heart failure by 35%. Based on the promising pharmacological profile of empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure, with or without diabetes,
This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.
Eligibility Criteria
Inclusion Criteria
- Male or female >18 years of age; Women of non-child-bearing potential must have a documentation of surgical sterilization (hysterectomy and/or bilateral oophorectomy) OR must have experienced menopause (no menses for >12 months). Women of child bearing potential must have a negative pregnancy test, AND must use highly effective methods of contraception during treatment with IP plus 5 days after the end of study drug administration.
- 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:
- Dyspnea at rest or with minimal exertion
- Signs of congestion, such as edema, rales, and/or congestion on chest radiograph
- 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)
- Treated with loop diuretics at screening
- Able to be randomized within 24 hours from presentation to the hospital
- Able and willing to provide freely given written informed consent
- eGFR (CKD-EPI) ≥30 ml/min/1.73m2 between presentation and randomization
Exclusion Criteria
- Diabetes Mellitus Type I
- Dyspnea primarily due to non-cardiac causes
- Cardiogenic shock
- Acute coronary syndrome within 30 days prior to randomization
- Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
- Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L)
- Pregnant or nursing (lactating) women
- Current participation in any interventional study
- Inability to follow instructions or comply with follow-up procedures
- 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.
Data sourced from ClinicalTrials.gov (NCT03200860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.