Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure

Sponsor
Medical University of Warsaw
Study ID
NCT05776043
Phase
PHASE3
Status
Unknown

Conditions

  • Acute Decompensated Heart Failure

Eligibility Criteria

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

Interventions

Study Details

National, multicenter, randomized, double-blind, parallel-group, stratified by SGLT-2 inhibitor type, placebo-controlled trial, - a Phase III study. Primary objective of the study is to investigate the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on clinical endpoints in patients hospitalized with acute/decompensated HF.

Key Dates

Start date
Mar 15, 2022
Status verified
Mar 2023
Primary completion
Sep 30, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
1,364 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: SGLT 2 Inhibitor
    Empagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment
  • Placebo Comparator: Placebo with a switch to SGLT 2 Inhibitor
    Placebo (n=682) for 3 months of treatment with a subsequent switch to Empagliflozin (n=341) or Dapagliflozin (n=341): 6 months of treatment

Primary Outcome Measure

Time to first event of adjudicated cardiovascular (CV) death, or adjudicated hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF) [ Time Frame: at 3 and 9 months ]

Central Contacts

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