Sedaghat-Hamedani Farbod, Amr Ali, Betz Theresa, Kayvanpour Elham, Reich Christoph, Wettstein Reto, Heinze Oliver, Mohr Isabell, Krisam Regina, Sander Anja, Klose Christina, Friedmann-Bette Birgit, Frey Norbert, Meder Benjamin
Medical Faculty of the University Heidelberg, Institute for Cardiomyopathies Heidelberg (ICH), Department of Internal Medicine III, University Hospital Heidelberg, Heidelberg, Germany.
DZHK (German Centre for Cardiovascular Research), Heidelberg-Mannheim, Germany.
ESC Heart Fail. 2024 Dec;11(6):4400-4406. doi: 10.1002/ehf2.14970. Epub 2024 Jul 15.
Dilated cardiomyopathy (DCM) is a leading cause of heart failure, particularly in younger individuals. Low physical strength is a global risk factor for cardiovascular mortality, and physical activity and a healthy lifestyle have been shown to improve outcomes in patients with heart failure. However, inappropriate exercise may increase the risk of arrhythmias in certain individuals with DCM. The determinants for predicting individual risks in this setting are poorly understood, and clinicians are hesitant to recommend sports for cardiomyopathy patients. The activeDCM trial aims to assess the safety and efficacy of a personalized exercise and activity programme for individuals with DCM.
The activeDCM trial is a prospective, randomized, interventional trial with a 12 month follow-up. Three hundred patients, aged 18-75 years with DCM, left ventricular ejection fraction (LVEF) ≤ 50% and New York Heart Association (NYHA) classes I-III, will be enrolled. The intervention includes a personalized exercise and activity programme. The primary outcome is the increase in peak oxygen uptake (VOmax, mL/kg/min) from baseline to 12 months. Secondary endpoints include adherence to personalized activity programmes, freedom from clinically relevant arrhythmia, unplanned hospitalization for heart failure and changes in NYHA class, quality of life scores, 6 min walk distance, muscular strength, N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity troponin T (hsTnT) levels and cardiac function. Advanced research questions include high-density phenome and omics analysis combined with digital biomarkers derived from Apple Watch devices.
The activeDCM trial will provide valuable insights into the safety and efficacy of personalized exercise training in DCM patients, inform clinical practice and contribute to the development of heart failure management programmes. The study will generate data on the impact of exercise on various aspects of cardiovascular disease, including genetic, metabolic, phenotypic and longitudinal aspects, facilitating the development of future digital tools and strategies, including the incorporation of smart wearable devices.
扩张型心肌病（DCM）是心力衰竭的主要病因，在年轻个体中尤为常见。体力低下是心血管疾病死亡的一个全球性风险因素，体育活动和健康的生活方式已被证明可改善心力衰竭患者的预后。然而，不适当的运动可能会增加某些DCM患者发生心律失常的风险。目前对于预测这一情况下个体风险的决定因素了解甚少，临床医生对于向心肌病患者推荐运动也犹豫不决。activeDCM试验旨在评估针对DCM患者的个性化运动和活动计划的安全性和有效性。
activeDCM试验是一项前瞻性、随机、干预性试验，随访期为12个月。将招募300名年龄在18 - 75岁之间、患有DCM、左心室射血分数（LVEF）≤50%且纽约心脏协会（NYHA）心功能分级为I - III级的患者。干预措施包括个性化运动和活动计划。主要结局指标是从基线到12个月时峰值摄氧量（VOmax，毫升/千克/分钟）的增加。次要终点包括对个性化活动计划的依从性、无临床相关心律失常、因心力衰竭而未计划的住院治疗以及NYHA心功能分级、生活质量评分、6分钟步行距离、肌肉力量、N末端B型利钠肽原（NT - proBNP）和高敏肌钙蛋白T（hsTnT）水平以及心脏功能的变化。高级研究问题包括高密度表型组学分析以及结合来自苹果手表设备的数字生物标志物。
activeDCM试验将为DCM患者个性化运动训练的安全性和有效性提供有价值的见解，为临床实践提供依据，并有助于心力衰竭管理计划的制定。该研究将生成关于运动对心血管疾病各个方面影响的数据，包括遗传、代谢、表型和纵向方面，促进未来数字工具和策略的开发，包括智能可穿戴设备的纳入。
