Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure
Condition: Heart Failure Acute; Heart Failure，Congestive; Heart Failure; With Decompensation
MeSH terms: Heart Failure
Intervention: Empagliflozin 10 MG; Placebo Oral Tablet
Intervention description: 10 mg daily, oral, 30 days; Matching Placebo, 10 mg daily, oral, 30 days
Intervention MeSH terms: Empagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, placebo-controlled, double-blind, parallel group, multicenter study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blind, placebo controlled
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart failure; diuretic response; empagliflozin

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:

               1. Dyspnea at rest or with minimal exertion

               2. Signs of congestion, such as edema, rales, and/or congestion on chest radiograph

               3. 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)

               4. 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.