Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR
Recruiting · NCT07185100 · Observational (researchers observe without assigning treatment) · Lead sponsor: German Heart Institute
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
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
Where it is running
1 location listed.
- Deutsches Herzzentrum der Charité - Berlin, Germany