Rationale and Design of the Dapagliflozin Effect on Cardiovascular Events in Acute Heart Failure (DAPA ACT HF)-TIMI 68 Trial
Language English Country United States Media print
Document type Clinical Trial Protocol, Journal Article
PubMed
40335233
DOI
10.1016/j.jchf.2025.03.014
PII: S2213-1779(25)00255-0
Knihovny.cz E-resources
- Keywords
- clinical trial, hospitalization, sodium-glucose cotransporter 2 inhibitors, worsening heart failure,
- MeSH
- Acute Disease MeSH
- Benzhydryl Compounds * therapeutic use administration & dosage MeSH
- Diabetes Mellitus, Type 2 complications drug therapy MeSH
- Double-Blind Method MeSH
- Sodium-Glucose Transporter 2 Inhibitors * therapeutic use MeSH
- Glucosides * therapeutic use administration & dosage MeSH
- Hospitalization MeSH
- Middle Aged MeSH
- Humans MeSH
- Multicenter Studies as Topic MeSH
- Randomized Controlled Trials as Topic MeSH
- Aged MeSH
- Heart Failure * drug therapy physiopathology MeSH
- Stroke Volume MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
- Names of Substances
- Benzhydryl Compounds * MeSH
- dapagliflozin MeSH Browser
- Sodium-Glucose Transporter 2 Inhibitors * MeSH
- Glucosides * MeSH
Although sodium-glucose cotransporter 2 inhibitors reduce the risk of cardiovascular death or worsening heart failure (HF) in patients with chronic HF, there are limited data on initiation in hospitalized patients with HF. DAPA ACT HF-TIMI 68 (Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68) is an international, randomized, double-blind trial evaluating the initiation of dapagliflozin (10 mg daily) vs placebo in 2,401 patients hospitalized for acute HF. Patients were enrolled irrespective of left ventricular ejection fraction, type 2 diabetes status, or chronicity of HF (de novo and worsening chronic HF). Randomized participants receive blinded treatment for 2 months. The primary efficacy endpoint is time to first occurrence of cardiovascular death or worsening HF (worsening HF during the index admission, rehospitalization for worsening HF, or urgent HF visit). Key safety endpoints include symptomatic hypotension and worsening kidney function. This is the first cardiovascular outcomes trial designed specifically to evaluate the efficacy and safety of in-hospital initiation of dapagliflozin in patients hospitalized for the management of acute HF. (Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68 [DAPA ACT HF-TIMI 68]; NCT04363697; EudraCT # 2022-001262-35).
Department of Cardiology Medical University of Lodz Lodz Poland
Department of Cardiology Montreal Heart Institute Université de Montréal Montreal Canada
Heart and Vascular Center Semmelweis University Budapest Hungary
Section of Endocrinology Yale University School of Medicine New Haven Connecticut USA
References provided by Crossref.org
ClinicalTrials.gov
NCT04363697
