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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
The TIMI Study Group
Study ID
NCT04363697
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin
  • Placebo — DRUG
    Matched placebo

Study Details

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.

Key Dates

Start date
Sep 24, 2020
Status verified
May 2026
Primary completion
Jun 2, 2025
Completion
Jun 2, 2025

Study Design

Enrollment
2,401 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg administered orally once daily for 2 months
  • Placebo Comparator: Placebo
    Matching placebo administered orally once daily for 2 months

Primary Outcome Measure

Participants With the Composite Outcome of Cardiovascular Death or Worsening Heart Failure [ Time Frame: 2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
TIMI Study GroupBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
TIMI Study Group· Boston, MA

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