Design & Rationale of the clinical trial: Cardiorenal Care on Wheels for Symptomatic and Asymptomatic Heart Failure Patients. ("WE-CARE-HF-CMR")

https://doi.org/10.1007/s00392-025-02737-x

Sebastian Kelle (Berlin)1, M. L. Müller (Berlin)1, R. E. Beyer (Berlin)1, T. Friede (Göttingen)2, J. Wieditz (Göttingen)2, V. Falk (Berlin)3, U. Landmesser (Berlin)4, G. Thiede (Berlin)1

1Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin | CBF Berlin, Deutschland; 2Universitätsmedizin Göttingen Institut für Medizinische Statistik Göttingen, Deutschland; 3Charité - Universitätsmedizin Berlin Klinik für kardiovaskuläre Chirurgie Berlin, Deutschland; 4Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin Berlin, Deutschland

 

Background
Asymptomatic heart failure (HF) is often overlooked, and when detected, there is a lack of early and effective preventive interventions. The clinical trial Cardiorenal Care on Wheels for Asymptomatic Heart Failure Patients using CMR (WE-CARE-HF-CMR), conducted in Germany in urban areas, aims to close this gap by evaluating the feasibility of a mobile, telemedicine-monitored screening approach using cardiac magnetic resonance imaging (CMR), quality of life assessment and laboratory tests as key elements.

Methods and Results
The WE-CARE-HF-CMR study is a prospective, non-randomized controlled single center study. The study will enroll using CMR approximately 450 asymptomatic patients aged 40 to 69 years who have no history of HF but have at least one of the following risk factors: arterial hypertension, hypercholesterolemia, obesity, smoking/tobacco use, chronic diabetes mellitus or chronic kidney disease. Participants will undergo a comprehensive screening examination that includes a questionnaire-based medical history, laboratory tests and a brief, non-contrast CMR examination at baseline. Using the imaging-derived global longitudinal strain (GLS), participants will be categorized as healthy or pre-HF (Stage B-HF). All participants will receive innovative medical reports, including guideline-based recommendations. Follow-up assessments will be conducted to evaluate the occurrence of adverse cardiac events, treatment changes, participant awareness and quality of life. The results will be compared with the results from the G-BA-Innovation fund project “HERZCheck”, which provides data from approximately 4.500 patients in rural and underressourced areas in Germany and has already be completed (NCT05122793).

Conclusion
WE-CARE-HF-CMR will provide a proposal for a comprehensive, contemporary screening approach for asymptomatic HF tailored to the needs of the target population. This will provide important new information on the prevalence of asymptomatic HF in at-risk patients in urban versus rural areas, as well as the feasibility, patient awareness and added diagnostic value of CMR testing as part of future screening mechanisms for HF in a sufficiently large patient population.

 

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