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

A Prospective, Cross-sectional, Nationwide Community-based Observational Study to Determine the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07185100
Acronym
WE-CARE-HF-CMR
Enrollment
600
Registered
2025-09-22
Start date
2025-09-13
Completion date
2036-12-31
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF), Renal Dysfunction, Stage B Heart Failure

Keywords

Prevention, Heart failure, HFpEF, Asymptomatic, Cardiology, Urban area, Germany, CMR, Cardiac Magnetic Resonance, HFrEF, Diastolic Dysfunction, Strain, mobile, GLS

Brief summary

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).

Detailed description

The WE-CARE-HF-CMR-study is a cross-sectional, nationwide prospective, community-based observational study to improve the diagnosis of heart failure in urban populations with characteristic risk factors for the occurrence of heart failure using telemedically-supervised mobile diagnostic units. The central diagnostic methods employed in the assessed screening routine comprise a questionnaire-based medical history, laboratory testing and a standardized, non-invasive imaging examination. Within the framework of the study, 600 subjects aged 40 to 69 years and of male, female or diverse gender, who have characteristic risk factors for the occurrence of asymptomatic heart failure will be examined. The central diagnostic imaging method of the study is a standardized, needle- as well as stress- and contrast-agent-free CMR exam. The examinations are carried out in mobile MRI diagnostic units at various clinic locations in 5 major cities (\> 1.000.000 residents) in Germany. The various clinics were recommended as locations because they offer good infrastructural conditions for setting up the mobile MRI diagnostic units, which are 27 t truck units, and because emergency medical care for the study participants can also be guaranteed. The medical staff of the clinics is not involved in the study. The potential study participants will be informed by the investigators of the DHZC in a video call either in a room rented specifically for this purpose or in an accompanying vehicle of the mobile MRI diagnostic unit. The consent of the study participants is also obtained via telemedicine and in accordance with current legal requirements in Germany. The planned examinations in the mobile diagnostic unit will be carried out exclusively by the staff of the company operating the MRI units on behalf of and under the telemedical supervision of the investigators and the study management of the DHZC, acting as the central unit.

Interventions

None listed

Sponsors

German Heart Institute
Lead SponsorOTHER
AstraZeneca
CollaboratorINDUSTRY
Philips Healthcare
CollaboratorINDUSTRY
Deutsches Herzzentrum der Charité, Berlin
CollaboratorUNKNOWN
German Heart Center Foundation
CollaboratorUNKNOWN
Nationale Herzallianz (NHA)
CollaboratorUNKNOWN
Deutsche Herzstiftung
CollaboratorUNKNOWN

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

Asymptomatic subjects with: * 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 * Obesity (known/diagnosed and/or BMI \> 30 (kg/m²)) and/or * Smoker (known/diagnosed and/or current/previous and/or medication/treatment) * Age 40-69 years * female or male or diverse sex * Ability to provide informed consent * Provision of Informed Consent

Exclusion criteria

* Inability to provide written informed consent * Diagnosed heart failure or previously detected reduced ejection fraction * General MRI

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of asymptomatic pre-heart failure (stage B) in an urban populationat baselineAsymptomatic pre-heart failure (stage B) is defined as CMR-derived global longitudinal strain (GLS) ≥ -15%

Secondary

MeasureTime frameDescription
Prevalence of chronic kidney disease (CKD)at baselineCKD is defined as eGFR \< 60%
Adherence to therapy1, 5 years and 10 years laterAssessed using the MARS-10 questionnaire

Countries

Germany

Contacts

CONTACTProf. Dr. Sebastian Kelle
sebastian.kelle@dhzc-charite.de+493045931182
CONTACTDr. Gisela Thiede
gisela.thiede@dhzc-charite.de+4915209192843
PRINCIPAL_INVESTIGATORSebastian Kelle, Prof. Dr.

Deutsches Herzzentrum der Charité

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026