Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)

Phase 4

Recruiting

• Conditions: Acute Heart Failure; Heart Failure
• Interventions: Drug: Placebo; Drug: Dapagliflozin

• Registration Number: NCT04363697
• Lead Sponsor: The TIMI Study Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-27
• Study Start: 2020-09-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31
• Primary Completion: 2024-01
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo administered orally once daily for 2 months
Dapagliflozin	Dapagliflozin	Dapagliflozin 10 mg administered orally once daily for 2 months

Primary Outcome Measures

Name	Time	Method
Cardiovascular (CV) death or worsening heart failure	2 months	Time to first occurrence of CV death or worsening heart failure

Secondary Outcome Measures

Name	Time	Method
Rehospitalization for heart failure, urgent heart failure visit	2 months	Time to first occurrence of rehospitalization for heart failure or urgent heart failure visit
Death	2 months	Time to death
Readmission	2 months	Readmission within 30 days of hospital discharge
CV death	2 months	Time to CV death
Composite CV death, rehospitalization for heart failure, urgent heart failure visit	2 months	Time to first occurrence of composite of CV death, rehospitalization for heart failure, or urgent heart failure visit
Composite CV death, rehospitalization for heart failure	2 months	Time to first occurrence of composite of CV death or rehospitalization for heart failure

Trial Locations

Locations (1)

TIMI Study Group; 🇺🇸 Boston, Massachusetts, United States