Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-69
SponsorGerman Heart Institute

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Patients at risk of heart failure

Trial outcomes

Primary outcomes

1

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%

Time frame
at baseline

Secondary outcomes

1

Prevalence of chronic kidney disease (CKD)

CKD is defined as eGFR \< 60%

Time frame
at baseline
2

Adherence to therapy

Assessed using the MARS-10 questionnaire

Time frame
1, 5 years and 10 years later

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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