NCT07185100 Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR
| NCT ID | NCT07185100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | German Heart Institute |
| Condition | Heart Failure With Preserved Ejection Fraction (HFPEF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-09-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2025-09-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Sebastian Kelle, Prof. Dr.
PRINCIPAL INVESTIGATOR
Deutsches Herzzentrum der Charité
Frequently Asked Questions
Who can join the NCT07185100 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 69 Years, studying Heart Failure With Preserved Ejection Fraction (HFPEF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07185100 currently recruiting?
Yes, NCT07185100 is actively recruiting participants. Contact the research team at sebastian.kelle@dhzc-charite.de for enrollment information.
Where is the NCT07185100 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07185100 clinical trial?
NCT07185100 is sponsored by German Heart Institute. The principal investigator is Sebastian Kelle, Prof. Dr. at Deutsches Herzzentrum der Charité. The trial plans to enroll 600 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.