Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure

Sponsor
Juntendo University
Study ID
NCT05392764
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Heart Failure

Eligibility Criteria

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

Interventions

  • Empagliflozin 10 MG — DRUG
    once-daily oral empagliflozin 10 mg
  • Placebo — DRUG
    Placebo matching empagliflozin 10 mg

Study Details

The EMPA-AHF trial is a multicentre, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of early initiation of once-daily oral empagliflozin 10 mg in patients hospitalized for patients with acute heart failure (AHF) who are at a high risk of adverse events.

Key Dates

Start date
Sep 10, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
444 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin
    Patients will be randomized 1:1 to either empagliflozin or placebo.
  • Placebo Comparator: Placebo
    Placebo matching empagliflozin

Primary Outcome Measure

A hierarchical composite endpoint consisting of death within 90 days, heart failure rehospitalization within 90 days, WHF during hospitalization, and urine output up to 48 hours after treatment initiation, assessed by the win ratio [ Time Frame: Up to 90 days ]

Central Contacts

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