Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocard… (NCT04363697) | Clinical Trial Compass
CompletedPhase 4
Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)
United States2,401 participantsStarted 2020-09-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Left ventricular ejection fraction (LVEF) measured within the past 12 months (including during the current hospitalization)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was testing dapagliflozin specifically in people hospitalized with acute heart failure — does my situation match that closely enough that the results would actually apply to me?
2Since this is a Phase 4 trial that has already completed, has the data been published, and what did it show about whether dapagliflozin reduced cardiovascular death or worsening heart failure in those patients?
3The trial measured a combined outcome of cardiovascular death and worsening heart failure — based on my specific type and severity of heart failure, which of those two risks is my doctor most concerned about for me personally?
4Dapagliflozin is already an approved medication — would my doctor consider prescribing it for my heart failure based on what this completed trial found, or is there a reason to wait or try a different approach first?
5Are there any risks or side effects from dapagliflozin that showed up in this acute heart failure population that I should weigh against the potential benefits before deciding anything with my care team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants With the Composite Outcome of Cardiovascular Death or Worsening Heart Failure
. 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)
Exclusion criteria
. 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
. (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