About this trial
Heart failure (HF) in patients at risk is often overlooked, and when detected, there is a lack of early and effective preventive interventions. The WE-CARE-HF-CMR study, conducted in large cities/metropol areas in Germany ( \> 1.000.000 inhabitants), aims to close this gap by evaluating the feasibility of a mobile, telemedicinemonitored HF-screening approach combining cardiac magnetic resonance imaging (CMR), quality of life assessment and laboratory tests as key elements in asymptomatic patients at risk. WE-CARE-HF-CMR will provide a proposal for a comprehensive, contemporary screening approach for patients at risk to develop 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.
The results of the study will be compared with the results from the "HERZCheck'' trial, which provides data from approximately 4,500 participants in rural areas in Germany and has already been completed (NCT05122793).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
chronic diabetes mellitus (known/diagnosed and/or antidiabetic medication and/or elevated HbA1C) and/or
renal impairment (known/diagnosed CKD and/or in laboratory CKD III° or higher) and/or
Hypertension (known/diagnosed and/or antihypertensive medication/treatment) and/or
Hypercholesterolaemia (known/diagnosed and/or antilipid medication/treatment) and/or
Disqualifiers
Inability to provide written informed consent
Diagnosed heart failure or previously detected reduced ejection fraction
General MRI exclusion criteria (pacemaker, defibrillator, intracranial aneurysm clips, metallic foreign bodies in the eyes)
Any MRI exclusion criteria not listed here, as determined by the MRI laboratory performing the procedure
Trial population
The population from which the groups or cohorts will be selected are asymptomatic adults from the urban areas of Berlin, Cologne, Frankfurt (Main), Hamburg, and Munich with no history of heart failure who have one or more risk factor for developing heart failure. They are either volunteers or referred from local cardiologists.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prevalence of asymptomatic pre-heart failure (stage B) in an urban population
Asymptomatic pre-heart failure (stage B) is defined as CMR-derived global longitudinal strain (GLS) ≥ -15%
Secondary outcomes
Prevalence of chronic kidney disease (CKD)
CKD is defined as eGFR \< 60%
Adherence to therapy
Assessed using the MARS-10 questionnaire
Sponsors and contacts
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German Heart Institute
Lead sponsor
AstraZeneca
Collaborator
Philips Healthcare
Collaborator
Deutsches Herzzentrum der Charité, Berlin
Collaborator
German Heart Center Foundation
Collaborator
Nationale Herzallianz (NHA)
Collaborator
Deutsche Herzstiftung
Collaborator