Design and rationale of the WE-CARE-HF-CMR trial: Cardiorenal care on wheels for asymptomatic heart failure patients (NCT07185100).

BACKGROUND

Heart failure (HF) is a significant public health concern. Early detection, particularly during the asymptomatic stage, is essential for prompt intervention and preventing progression. Conventional measures, such as left ventricular ejection fraction (LVEF) have limited sensitivity. However, left ventricular global longitudinal strain (GLS) can detect subclinical myocardial dysfunction. Preliminary data from the previous HERZCHECK study showed that 23% (1023/4509) of participants in rural Germany had GLS-defined subclinical pre-HF (stage B HF) when examined with mobile cardiac MRI units. Yet, the prevalence of asymptomatic HF in urban populations remains unclear. The WE-CARE-HF-CMR trial aims to address this issue.

STUDY DESIGN AND METHODOLOGY: The WE-CARE-HF-CMR trial is a single-center prospective observational study with a cross-sectional baseline assessment and an exploratory longitudinal follow-up conducted in five urban German cities (Berlin, Cologne, Frankfurt, Hamburg, Munich; NCT07185100). Asymptomatic patients between the ages of 40 and 69 with cardiovascular risk factors but without a history of symptomatic HF are enrolled via outpatient physician referral or self-referral. Participants undergo a standardized diagnostic evaluation including a medical history review, laboratory testing, cardiovascular magnetic resonance (CMR) imaging with GLS analysis, and quality-of-life questionnaires. CMR examinations are performed using both stationary and mobile magnetic resonance imaging (MRI) units. Subclinical pre-HF (stage B HF) is defined as GLS ≥ -15%. The primary endpoint is the prevalence of subclinical pre-HF (stage B HF) in the urban population. Secondary endpoints assess therapy adherence, quality of life, and the prevalence of chronic kidney disease. CMR images are analyzed centrally following standardized protocols to ensure comparability with HERZCHECK rural data.

CONCLUSION

The WE-CARE-HF-CMR trial will provide critical data on the prevalence of subclinical pre-HF (stage B HF) in urban populations. Using CMR-based GLS analysis with stationary and mobile units, and building on the HERZCHECK trial methodology, the study will close the diagnostic gap between rural and urban areas. These findings may ultimately support the implementation of targeted screening programs for subclinical pre-HF (stage B HF) to enable early intervention and prevent the progression to symptomatic HF.

GOV IDENTIFIER: NCT07185100.