NCT04363697

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

Completed Phase 4 Last updated 24 June 2025

What this trial tests

Phase 4 trial testing Dapagliflozin in Acute Heart Failure in 2,401 participants. Completed in 2 June 2025.

Timeline

24 September 2020

Primary endpoint
2 June 2025

2 June 2025

Quick facts

Lead sponsor	The TIMI Study Group
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	2,401
Start date	24 September 2020
Primary completion	2 June 2025
Estimated completion	2 June 2025
Sites	1 location across United States

Drugs / interventions tested

• Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
• Placebo

Conditions studied

• Acute Heart Failure — all drugs for Acute Heart Failure →
• Heart Failure — all drugs for Heart Failure →

Sponsor

The TIMI Study Group — full company profile →

Who can join

18 and older, any sex, with Acute Heart Failure or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dapagliflozin in heart failure with preserved and mildly reduced ejection fraction: rationale and design of the DELIVER trial.
   Solomon SD, de Boer RA, DeMets D, Hernandez AF, et al · · 2021 · cited 227× · PMID 34051124 · DOI 10.1002/ejhf.2249
2. Time to Clinical Benefit of Dapagliflozin and Significance of Prior Heart Failure Hospitalization in Patients With Heart Failure With Reduced Ejection Fraction.
   Berg DD, Jhund PS, Docherty KF, Murphy SA, et al · · 2021 · cited 130× · PMID 33595593 · DOI 10.1001/jamacardio.2020.7585
3. Sodium-glucose co-transporter 2 inhibitors as an early, first-line therapy in patients with heart failure and reduced ejection fraction.
   Tomasoni D, Fonarow GC, Adamo M, Anker SD, et al · · 2022 · cited 89× · PMID 34894038 · DOI 10.1002/ejhf.2397
4. Edema formation in congestive heart failure and the underlying mechanisms.
   Abassi Z, Khoury EE, Karram T, Aronson D. · · 2022 · cited 48× · PMID 36237903 · DOI 10.3389/fcvm.2022.933215
5. The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction.
   Brownell NK, Ziaeian B, Fonarow GC. · · 2021 · cited 37× · PMID 34950508 · DOI 10.15420/cfr.2021.18
6. Applicability of US Food and Drug Administration Labeling for Dapagliflozin to Patients With Heart Failure With Reduced Ejection Fraction in US Clinical Practice: The Get With the Guidelines-Heart Failure (GWTG-HF) Registry.
   Vaduganathan M, Greene SJ, Zhang S, Grau-Sepulveda M, et al · · 2021 · cited 24× · PMID 33185662 · DOI 10.1001/jamacardio.2020.5864
7. Sodium-glucose co-transporter 2 inhibitors in heart failure: an updated evidence-based practical guidance for clinicians.
   Monzo L, Ferrari I, Cicogna F, Tota C, et al · · 2023 · cited 23× · PMID 37125324 · DOI 10.1093/eurheartjsupp/suad055
8. SGLT2 Inhibitors in Acute Heart Failure: A Meta-Analysis of Randomized Controlled Trials.
   Ul Amin N, Sabir F, Amin T, Sarfraz Z, et al · · 2022 · cited 19× · PMID 36553880 · DOI 10.3390/healthcare10122356