Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)
NCT04363697 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2401
Last updated 2025-06-24
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.
Conditions
- Acute Heart Failure
- Heart Failure
Interventions
- DRUG
-
Dapagliflozin
- DRUG
-
Matched placebo
Sponsors & Collaborators
- collaborator INDUSTRY
-
Worldwide Clinical Trials
collaborator OTHER -
The TIMI Study Group
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-24
- Primary Completion
- 2025-06-02
- Completion
- 2025-06-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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