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Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
  • Healthy Volunteers


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.


Full study 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 With Heart Failure With Reduced Ejection Fraction 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)
Protocol number OCR38864 ID NCT04363697
Phase Phase 4


Inclusion Criteria

  1. Age ≥18 years (male or female)

  2. Currently hospitalized for AHF defined as meeting all the following criteria:

    1. 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)

    2. 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)

    3. Intensification of AHF therapy during admission defined as at least one of the


i. 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) The majority of enrolled patients should have an established history of heart failure (defined as present for ≥2 months and for which the patient is on treatment). Trial leadership will monitor this proportion and may cap enrollment of patients without an established history of heart failure (i.e., patients presenting with de novo heart failure).

  1. Left ventricular ejection fraction (LVEF) measured within the past 12 months (including during the current hospitalization)

  2. Elevated NT-proBNP or BNP during current hospitalization:

    1. 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)

    2. 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)

  3. 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:

    1. No increase (i.e., intensification) in the dose of intravenous diuretics during the 12 hours prior to randomization

    2. No use of intravenous vasodilators or inotropes during the 24 hours prior to randomization

Patients across the spectrum of LVEF are eligible for participation in the trial. Trial

leadership will monitor the proportion of patients with various LVEFs and may cap

enrollment of certain subgroups to ensure a broad population.

In addition, patients with and without type 2 diabetes are eligible for participation in

the trial. Trial leadership will monitor the proportion of patients with and without type 2

diabetes and may cap enrollment of one subgroup to ensure adequate representation of the


Exclusion Criteria

  1. Symptomatic hypotension in the past 24 hours

  2. Concurrent use of two or more intravenous inotropic agents during the index hospitalization

  3. eGFR

Lead researcher

  • Cardiologist (Heart Specialist), Advanced Heart Failure and Transplant Specialist
    Languages: Spanish
    Juan Vilaro

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step


    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.