洋地黄毒苷改善晚期慢性心力衰竭患者的预后（DIGIT-HF）：与近期随机对照心力衰竭试验相比的基线特征
DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials.
作者信息
Bavendiek Udo, Thomas Nele Henrike, Berliner Dominik, Liu Xiaofei, Schwab Johannes, Rieth Andreas, Maier Lars S, Schallhorn Sven, Angelini Eleonora, Soltani Samira, Rathje Fabian, Sandu Mircea-Andrei, Geller Welf, Gaspar Thomas, Hambrecht Rainer, Zdravkovic Marija, Philipp Sebastian, Kosevic Dragana, Nickenig Georg, Scheiber Daniel, Winkler Sebastian, Becher Peter Moritz, Lurz Philipp, Hülsmann Martin, von Karpowitz Maria, Schröder Christoph, Neuhaus Barbara, Seltmann Anika, von der Leyen Heiko, Veltmann Christian, Störk Stefan, Böhm Michael, Koch Armin, Großhennig Anika, Bauersachs Johann
机构信息
Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
Institute for Biostatistics, Hannover Medical School, Hannover, Germany.
出版信息
Eur J Heart Fail. 2025 Jul;27(7):1224-1233. doi: 10.1002/ejhf.3679. Epub 2025 May 19.
AIMS
This report presents the baseline characteristics of patients enrolled in the DIGIT-HF trial and compares them with participants from recent trials with improved outcomes in patients with heart failure (HF) and a reduced ejection fraction (HFrEF).
METHODS AND RESULTS
DIGIT-HF, a randomized, double-blind, placebo-controlled, multicentre trial enrolling patients with symptomatic HFrEF (New York Heart Association [NYHA] functional class II and left ventricular ejection fraction [LVEF] ≤30%, or NYHA class III-IV and LVEF ≤40%), compares the efficacy and safety of digitoxin versus placebo in addition to standard treatment. Most baseline characteristics of the intention-to-treat population (1212 patients, mean age 66 ± 11 years, 20% women, mean LVEF 29 ± 7%) were similar to those in recent HFrEF trials. The distribution of NYHA class II, III, and IV was 30%, 66% and 4%, respectively, and indicates that the patients were sicker than in comparator HFrEF trials. Less patients had atrial fibrillation (27%) than those in recent HFrEF trials, but prescription rates of background therapy with beta-blockers (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (95%), mineralocorticoid receptor antagonists (76%), and diuretics (87%) were high and similar. Overall, 40% of patients were on angiotensin receptor-neprilysin inhibitors, 19% on sodium-glucose cotransporter 2 inhibitors, and 9% on ivabradine. Rates of implantable cardioverter-defibrillator (ICD, 64%) and cardiac resynchronization therapy (CRT, 25%) devices were much higher than in recent HFrEF trials.
CONCLUSIONS
Patients included in DIGIT-HF display a more severe HF symptom burden and higher rates of ICD/CRT implants compared to participants in recent HFrEF trials, while pharmacotherapy was largely similar.
CLINICAL TRIAL REGISTRATION
EudraCT (2013-005326-38).
目的
本报告介绍了参与DIGIT-HF试验患者的基线特征，并将其与近期心力衰竭（HF）伴射血分数降低（HFrEF）试验中结局改善的参与者进行比较。
方法与结果
DIGIT-HF是一项随机、双盲、安慰剂对照、多中心试验，纳入有症状的HFrEF患者（纽约心脏协会[NYHA]心功能II级且左心室射血分数[LVEF]≤30%，或NYHA III-IV级且LVEF≤40%），除标准治疗外，比较洋地黄毒苷与安慰剂的疗效和安全性。意向性治疗人群（1212例患者，平均年龄66±11岁，20%为女性，平均LVEF 29±7%）的大多数基线特征与近期HFrEF试验相似。NYHA II级、III级和IV级的分布分别为30%、66%和4%，表明这些患者比对照HFrEF试验中的患者病情更重。房颤患者（27%）少于近期HFrEF试验，但β受体阻滞剂（96%）、血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂/血管紧张素受体脑啡肽酶抑制剂（95%）、盐皮质激素受体拮抗剂（76%）和利尿剂（87%）的背景治疗处方率较高且相似。总体而言，40%的患者使用血管紧张素受体脑啡肽酶抑制剂，19%使用钠-葡萄糖协同转运蛋白2抑制剂，9%使用伊伐布雷定。植入式心脏复律除颤器（ICD，64%）和心脏再同步治疗（CRT，25%）装置的使用率远高于近期HFrEF试验。
结论
与近期HFrEF试验的参与者相比，DIGIT-HF纳入的患者显示出更严重的HF症状负担和更高的ICD/CRT植入率，而药物治疗基本相似。
临床试验注册
EudraCT（2013-005326-38）。
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