A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to Evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients Who Have Been Stabilized During Hospitalization for Acute Heart Failure DAPAgliflozin and Effect on Cardiovascular Events in ACuTe Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)

The TIMI Study Group1 site in 1 country2,401 target enrollmentSeptember 24, 2020

ConditionsAcute Heart Failure Heart Failure

InterventionsDapagliflozin Placebo

DrugsDapagliflozin Placebo

Overview

Phase: Phase 4
Intervention: Dapagliflozin
Conditions: Acute Heart Failure
Sponsor: The TIMI Study Group
Enrollment: 2401
Locations: 1
Primary Endpoint: Cardiovascular (CV) death or worsening heart failure
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an international, multicenter, parallel-group, randomized, double-blind, placebo-controlled trial in patients who have been stabilized during hospitalization for acute heart failure, evaluating the effect of in-hospital initiation of dapagliflozin versus placebo on the clinical outcome of cardiovascular death or worsening heart failure.

Registry

clinicaltrials.gov

Start Date

September 24, 2020

End Date

June 2, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The TIMI Study Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Dapagliflozin

Dapagliflozin 10 mg administered orally once daily for 2 months

Intervention: Dapagliflozin

Placebo

Matching placebo administered orally once daily for 2 months

Intervention: Placebo

Outcomes

Primary Outcomes

Cardiovascular (CV) death or worsening heart failure

Time Frame: 2 months

Time to first occurrence of CV death or worsening heart failure

Secondary Outcomes

Death(2 months)
Readmission(2 months)
Composite CV death, rehospitalization for heart failure, urgent heart failure visit(2 months)
Composite CV death, rehospitalization for heart failure(2 months)
Rehospitalization for heart failure, urgent heart failure visit(2 months)
CV death(2 months)