Affiliation:
1. Medical Faculty of the University Heidelberg, Institute for Cardiomyopathies Heidelberg (ICH), Department of Internal Medicine III University Hospital Heidelberg Heidelberg Germany
2. DZHK (German Centre for Cardiovascular Research) Heidelberg‐Mannheim Germany
3. Informatics for Life Heidelberg Germany
4. Department of Sports Medicine Medical Clinic, University Hospital Heidelberg Heidelberg Germany
5. Institute of Medical Informatics Heidelberg University Hospital Heidelberg Germany
6. Institute of Medical Biometry University of Heidelberg Heidelberg Germany
Abstract
AbstractBackgroundDilated 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.Study DesignThe 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 (VO2max, 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.DiscussionThe 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.