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Acute Heart FailurePhase 4NCT04363697

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

A Phase 4 study testing Dapagliflozin in people with Acute Heart Failure and Heart Failure, run by The TIMI Study Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Heart Failure, Heart Failure
What is being tested?
Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,401 participants
Where
1 siteUnited States
Study dates
24 Sep 2020to 2 Jun 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years (male or female)
  • Currently hospitalized for AHF defined as meeting all the following criteria:
  • Presentation with worsening symptoms of heart failure (e.g., worsening dyspnea or dyspnea at rest, progressive fatigue, rapid weight gain, worsening edema/abdominal distention/anasarca)
  • Objective signs or diagnostic testing consistent with volume overload (e.g., jugular venous distension, pulmonary basilar crackles, S3 gallop, ascites, hepatomegaly, peripheral edema, radiological evidence of pulmonary congestion, noninvasive or invasive hemodynamic evidence of elevated filling pressures)
  • Intensification of AHF therapy during admission defined as at least one of the following:
  • Augmentation of oral diuretic therapy [e.g., ≥2x outpatient regimen dose, addition of a second diuretic agent, or new initiation of diuretic therapy in a previously naïve patient] ii. Initiation of intravenous diuretic therapy iii. Initiation of intravenous vasoactive agent (e.g., inotrope or vasodilator)
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  • Left ventricular ejection fraction (LVEF) measured within the past 12 months (including during the current hospitalization)
  • Elevated NT-proBNP or BNP during current hospitalization:
  • For patients with LVEF ≤40%: NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL (NT-proBNP ≥2400 pg/mL or BNP ≥600 pg/mL if patient in atrial fibrillation or atrial flutter)
  • For patients with LVEF >40%: NT-proBNP ≥1200 pg/mL or BNP ≥300 pg/mL (NT-proBNP ≥1800 pg/mL or BNP ≥450 pg/mL if patient in atrial fibrillation or atrial flutter)
  • Eligible patients will be randomized no earlier than 24 hours and up to 14 days after presentation while still hospitalized once they have been stabilized, as defined by:
  • No increase (i.e., intensification) in the dose of intravenous diuretics during the 12 hours prior to randomization
  • No use of intravenous vasodilators or inotropes during the 24 hours prior to randomization

Who cannot join

  • Symptomatic hypotension in the past 24 hours
  • Concurrent use of two or more intravenous inotropic agents during the index hospitalization
  • eGFR <25 ml/min/1.73 m2 as measured by the CKD-EPI equation at screening or rapidly progressive renal disease
  • Current use of an SGLT2 inhibitor
  • Prior intolerance of SGLT2 inhibitors
  • Type 1 diabetes mellitus or history of diabetic ketoacidosis
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  • (Only applies to patients with T2DM who are on insulin and/or a sulfonylurea) History of recurrent major hypoglycemia (i.e., resulting in severe impairment in consciousness or behavior, or requiring emergency external assistance)
  • Implantation of a cardiac resynchronization therapy (CRT) device or valve repair or replacement within 30 days prior to randomization or intent to do so during the trial
  • ST-segment elevation myocardial infarction or coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 30 days prior to randomization or intent to undergo coronary revascularization during the trial
  • Untreated sustained ventricular arrhythmias or Mobitz type II or third-degree heart block (i.e., without an ICD or pacemaker, respectively)
  • History of heart transplantation or current transplant listing; mechanical circulatory support use (either durable or temporary) during the index hospitalization
  • History of heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, uncorrected primary valvular disease, complex congenital heart disease, or heart failure felt to be due to a transient process (e.g., stress [takotsubo] cardiomyopathy, tachycardia-induced cardiomyopathy) expected to resolve within 2 months.
  • History of end-stage liver disease
  • Women of child-bearing potential (unless using adequate contraception) or currently breastfeeding
  • Current participation in a clinical trial with an unlicensed drug or device
  • Study staff or their family members
  • Any condition that, in the opinion of the investigator, would make trial participation not in the best interest of the subject, or would compromise compliance with the trial protocol (e.g., active severe infection, active malignancy)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • TIMI Study Group

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: 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)

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.

Being tested
Dapagliflozin, Placebo
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04363697
Study groupRoleWhat they receive
DapagliflozinExperimentalDapagliflozin 10 mg administered orally once daily for 2 months
Receives: Drug: Dapagliflozin
PlaceboPlacebo comparatorMatching placebo administered orally once daily for 2 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants With the Composite Outcome of Cardiovascular Death or Worsening Heart Failure

    Composite of cardiovascular death or worsening heart failure event (defined as worsening heart failure during index admission, rehospitalization for worsening heart failure, or urgent heart failure visit)

    Measured: 2 months

Secondary outcomes (5)

  1. Participants With the Composite Outcome of Cardiovascular Death, Rehospitalization for Heart Failure, Urgent Heart Failure Visit

    Measured: 2 months

  2. Participants With the Composite Outcome of Cardiovascular Death or Rehospitalization for Heart Failure

    Measured: 2 months

  3. Participants With Rehospitalization for Heart Failure or Urgent Heart Failure Visit

    Measured: 2 months

  4. Number of Participants With All-cause Death

    Measured: 2 months

  5. Hierarchical Composite of Time to Cardiovascular Death, Worsening Heart Failure Events, Time to First Worsening Heart Failure Event, and Change From Baseline in KCCQ-12 Total Symptom Score (% Wins)

    Hierarchical Composite Endpoint combines time to all-cause mortality, number of heart failure events, time to first worsening HF events, KCCQ-12 total symptom score in a hierarchical fashion. The method compares every participant with every other participant within strata, assigning a +1 to the "better" participant and a -1 to the "worse" participant and 0 if they are "tied". 'Win' represents a participant doing better based on hierarchical comparison. The reported unit is the total number of "wins" for each treatment group from performing such a hierarchical comparison across stratification factors in the study.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2020
  2. Study start24 Sep 2020
  3. Primary completion2 Jun 2025
  4. Study completion2 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04363697
Sponsor's protocol ID
D1690C00078
Status last verified
May 2026
First submitted
23 Apr 2020
Last updated
16 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.

    PubMed 21900289

  • Small AM, Patel SM, Thomas C, Palazzolo MG, Belohlavek J, Desai AS, Drozdz J, Inzucchi SE, McMurray JJV, Merkely B, O'Meara E, Verma S, Wiviott SD, Sabatine MS, Berg DD. Effect of In-Hospital Initiation of Dapagliflozin on Decongestion in Patients Hospitalized for Heart Failure: An Analysis of the DAPA ACT HF-TIMI 68 Trial. JACC Heart Fail. 2026 Aug 30:103366. doi: 10.1016/j.jchf.2026.103366. Online ahead of print.

    PubMed 42669075

  • Berg DD, Patel SM, Haller PM, Cange AL, Palazzolo MG, Bellavia A, Kuder JF, Desai AS, Inzucchi SE, McMurray JJV, O'Meara E, Verma S, Belohlavek J, Drozdz J, Merkely B, Ogunniyi MO, Drasnar T, Izzo JL, Sarman B, McGinty JE, Ramanathan K, Mulkay AJ, Przybylski A, Ruff CT, O'Donoghue ML, Murphy SA, Sabatine MS, Wiviott SD; DAPA ACT HF-TIMI 68 Trial Committees and Investigators. Dapagliflozin in Patients Hospitalized for Heart Failure: Primary Results of the DAPA ACT HF-TIMI 68 Randomized Clinical Trial and Meta-Analysis of Sodium-Glucose Cotransporter-2 Inhibitors in Patients Hospitalized for Heart Failure. Circulation. 2025 Nov 18;152(20):1411-1422. doi: 10.1161/CIRCULATIONAHA.125.076575. Epub 2025 Aug 29.

    PubMed 40884036

  • Berg DD, Patel SM, Haller PM, Belohlavek J, Desai AS, Drozdz J, Inzucchi SE, McMurray JJV, Merkely B, O'Meara E, Verma S, Cange AL, Murphy SA, Sabatine MS, Wiviott SD. Rationale and Design of the Dapagliflozin Effect on Cardiovascular Events in Acute Heart Failure (DAPA ACT HF)-TIMI 68 Trial. JACC Heart Fail. 2025 May;13(5):829-839. doi: 10.1016/j.jchf.2025.03.014.

    PubMed 40335233

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin in people with Acute Heart Failure and Heart Failure, run by The TIMI Study Group at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With the Composite Outcome of Cardiovascular Death or Worsening Heart Failure (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04363697, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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