Rationale and design of the HERZCHECK trial: Detection of early heart failure using telemedicine and cardiovascular magnetic resonance in structurally weak regions (NCT05122793).

BACKGROUND AND AIMS

Heart failure (HF) is an imminent global health problem. Yet established screening algorithms for asymptomatic pre-HF, allowing for early and effective preventive interventions, are largely lacking. The HERZCHECK trial, conducted in structurally underserved rural regions of North-Eastern Germany, aims to close this gap by evaluating the feasibility, diagnostic efficacy, and cost-effectiveness of a fully mobile, telemedically-supervised screening approach, combining cardiovascular magnetic resonance (CMR) imaging and laboratory testing as central elements.

STUDY DESIGN AND METHODOLOGY

The HERZCHECK trial is a prospective, randomized controlled trial employing a prospective randomized open blinded endpoint design. The study targets asymptomatic adults aged 40-69 years without a history of HF, but with at least one of the following cardiovascular risk factors: hypertension, hypercholesterolemia, obesity, smoking/tobacco consumption, chronic diabetes mellitus, or chronic kidney disease. Participants undergo a comprehensive screening examination including a questionnaire-based medical history, laboratory testing, and CMR at baseline. Based on CMR-derived global longitudinal strain (GLS), participants are classified as stratum A (GLS < -15%), B (GLS ≥ -15% to < -11%), or C (GLS ≥ -11%), with strata B and C being defined as asymptomatic pre-HF. Ten percent of participants in stratum A and all of stratum B and C are subsequently randomized into two groups, receiving either conventional or innovative medical reports, the latter including information on GLS, guideline-based recommendations, and access to a lifestyle intervention app for cardiovascular prevention. Additionally, treating physicians of participants in the innovative group are granted access to an expert center for telemedical inquiries. Follow-up assessments are performed over 12 months to evaluate changes in GLS, as well as adverse cardiac events and quality of life.

CONCLUSION

HERZCHECK aims to provide a blueprint for a comprehensive, contemporary screening approach tailored to the needs of the targeted structurally underserved population. By implementing this approach in a representative at-risk cohort, HERZCHECK will provide important new information about (a) the prevalence of asymptomatic pre-HF in at-risk patients and (b) the feasibility, added diagnostic value and health economic aspects of CMR exams as part of future screening mechanisms for HF in clinical routine care (NCT05122793).