Rationale and Design of the Dapagliflozin Effect on Cardiovascular Events in Acute Heart Failure (DAPA ACT HF)-TIMI 68 Trial

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure Pub Date : 2025-05-01 DOI:10.1016/j.jchf.2025.03.014

David D. Berg MD, MPH , Siddharth M. Patel MD, MPH , Paul M. Haller MD, PhD , Jan Bělohlávek MD, PhD , Akshay S. Desai MD, MPH , Jarosław Drożdż MD, PhD , Silvio E. Inzucchi MD , John J.V. McMurray MD , Béla Merkely MD, PhD , Eileen O’Meara MD , Subodh Verma MD, PhD , Abby L. Cange BS , Sabina A. Murphy MPH , Marc S. Sabatine MD, MPH , Stephen D. Wiviott MD

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引用次数: 0

Abstract

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)

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达格列净对急性心力衰竭患者心血管事件的影响(DAPA ACT HF)-TIMI 68试验的基本原理和设计

尽管钠-葡萄糖共转运蛋白2抑制剂可降低慢性心衰患者心血管死亡或加重心衰（HF）的风险，但住院心衰患者的初始化数据有限。DAPA ACT HF- timi 68 （dapag列净和对急性心力衰竭心血管事件的影响-心肌梗死溶栓68）是一项国际随机双盲试验，在2401例急性心力衰竭住院患者中评估dapag列净（每天10mg）与安慰剂的起始治疗。无论左室射血分数、2型糖尿病状态或HF的慢性程度（新发和恶化的慢性HF），患者都被纳入研究。随机受试者接受盲法治疗2个月。主要疗效终点是首次发生心血管死亡或HF恶化的时间（住院期间HF恶化，因HF恶化而再次住院，或HF紧急就诊）。主要安全终点包括症状性低血压和肾功能恶化。这是第一个专门设计的心血管结局试验，旨在评估住院治疗急性心衰的患者在医院内开始使用达格列净的有效性和安全性。达格列净对急性心衰心血管事件的影响——心肌梗死溶栓[DAPA ACT HF-TIMI 68]；NCT04363697;草案# 2022-001262-35)

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来源期刊

JACC. Heart failure CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

21.20

自引率

2.30%

发文量

164

期刊介绍： JACC: Heart Failure publishes crucial findings on the pathophysiology, diagnosis, treatment, and care of heart failure patients. The goal is to enhance understanding through timely scientific communication on disease, clinical trials, outcomes, and therapeutic advances. The Journal fosters interdisciplinary connections with neuroscience, pulmonary medicine, nephrology, electrophysiology, and surgery related to heart failure. It also covers articles on pharmacogenetics, biomarkers, and metabolomics.