Berg David D, Patel Siddharth M, Haller Paul M, Bělohlávek Jan, Desai Akshay S, Drożdż Jarosław, Inzucchi Silvio E, McMurray John J V, Merkely Béla, O'Meara Eileen, Verma Subodh, Cange Abby L, Murphy Sabina A, Sabatine Marc S, Wiviott Stephen D
TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
JACC Heart Fail. 2025 May;13(5):829-839. doi: 10.1016/j.jchf.2025.03.014.
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).
尽管钠-葡萄糖协同转运蛋白2抑制剂可降低慢性心力衰竭患者心血管死亡或心力衰竭（HF）恶化的风险，但关于住院HF患者起始使用该类药物的数据有限。达格列净治疗急性心力衰竭对心血管事件的影响-心肌梗死溶栓68试验（DAPA ACT HF-TIMI 68）是一项国际、随机、双盲试验，旨在评估2401例因急性HF住院的患者起始使用达格列净（每日10 mg）与安慰剂的疗效。入选患者不受左心室射血分数、2型糖尿病状态或HF病程（新发和慢性HF恶化）的影响。随机分组的参与者接受为期2个月的盲法治疗。主要疗效终点是首次发生心血管死亡或HF恶化的时间（在本次住院期间HF恶化、因HF恶化再次住院或紧急HF就诊）。关键安全终点包括症状性低血压和肾功能恶化。这是首个专门设计用于评估因急性HF住院患者住院期间起始使用达格列净的疗效和安全性的心血管结局试验。（达格列净治疗急性心力衰竭对心血管事件的影响-心肌梗死溶栓68试验[DAPA ACT HF-TIMI 68]；NCT04363697；欧盟临床试验编号#2022-001262-35）
