EMPA Acute Heart Failure

Sponsor
RWTH Aachen University
Study ID
NCT03554200
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Standard of Care + Empagliflozin: 10 mg (tablets) once daily
  • Placebo — DRUG
    Standard of Care + Placebo: Matching Placebo (tablets) once daily

Study Details

In this study the investigators are aiming to treat patients with acute heart failure with or without diabetes with Empagliflozin or placebo. Given the beneficial effects of Empagliflozin on heart failure hospitalization in the EMPA-REG OUTCOME trial, the investigators do expect a similar beneficial effect to be present in patients with acute heart failure. Acute heart failure is a state of hydropic decompensation resulting in dyspnea and congestions, caused by different etiologies of cardiac disease. Recompensation is reached by application of diuretic drugs and fluid restriction.

Key Dates

Start date
Jun 11, 2018
Status verified
Oct 2022
Primary completion
Oct 29, 2020
Completion
Oct 29, 2020

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin
    Patients will receive empagliflozin 10 mg qd for a period of 30 days.
  • Placebo Comparator: Placebo
    Patients of the placebo arm will receive placebo tablets qd for a period of 30 days.

Primary Outcome Measure

effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure [ Time Frame: 30 days ]

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