Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR (WE-CARE-HF-CMR)

March 26, 2026 updated by: Sebastian Kelle, German Heart Institute

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

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).

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 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
  • Haemodynamically unstable participants (heart rate < 45/min, systolic blood pressure < 90 mmHg)
  • Claustrophobia
  • Sensorineural hearing loss of 30 dB or more and tinnitus
  • Acute mental disorders requiring therapy
  • In the presence of pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients at risk of heart failure
asymptomatic individuals, residing in urban areas in Germany, between the age of 40 to 69 years without known HF and at least one established cardiovascular risk factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of asymptomatic pre-heart failure (stage B) in an urban population
Time Frame: at baseline
Asymptomatic pre-heart failure (stage B) is defined as CMR-derived global longitudinal strain (GLS) ≥ -15%
at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of chronic kidney disease (CKD)
Time Frame: at baseline
CKD is defined as eGFR < 60%
at baseline
Adherence to therapy
Time Frame: 1, 5 years and 10 years later
Assessed using the MARS-10 questionnaire
1, 5 years and 10 years later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Heart Institute

Collaborators

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

Investigators

  • Principal Investigator: Sebastian Kelle, Prof. Dr., Deutsches Herzzentrum der Charité

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2036

Study Registration Dates

First Submitted

September 10, 2025

First Submitted That Met QC Criteria

September 17, 2025

First Posted (Actual)

September 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WE-CARE-HF-CMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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