Actively Recruiting

Age: 40Years - 69Years
All Genders
ID07185100

A Nationwide Observational Study to Find Unrecognized Heart Failure in Urban Adults at Risk Using Mobile CMR in Germany

Led by German Heart Institute · Updated on 2026-04-01

600

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

G

German Heart Institute

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the prevalence of unrecognized heart failure in adults aged 40 to 69 years who have risk factors but show no symptoms. This observational study focuses on urban populations in large German cities with over 1 million residents, aiming to improve early detection of heart failure and provide a modern screening approach tailored to at-risk patients. The study also compares its findings with a previous trial conducted in rural areas to better understand differences in heart failure prevalence. The study uses a mobile, telemedicine-monitored screening method that includes a non-invasive cardiac magnetic resonance imaging (CMR) examination without needles, stress, or contrast agents. Participants undergo laboratory tests and quality of life assessments in specially equipped mobile MRI units stationed in major cities. Medical staff operate the mobile units under telemedical supervision, and participant consent is obtained remotely via video calls. Participants will complete questionnaires, blood tests, and the CMR exam at the mobile units. Researchers will track the prevalence of asymptomatic pre-heart failure and chronic kidney disease, as well as adherence to therapy over several years. The study will monitor participants' health status at baseline and follow-up points through questionnaires and laboratory data, with the entire participation process occurring in community-based settings to ensure convenience and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged between 40 and 69 years
  • Asymptomatic individuals with at least one of the following: diabetes, chronic kidney disease, hypertension, high cholesterol, obesity (BMI > 30), or smoking history
  • Male, female, or diverse gender
  • Ability to provide informed consent
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Unable to provide written informed consent
  • Diagnosed heart failure or prior reduced heart function
  • Standard MRI contraindications such as pacemaker, defibrillator, intracranial aneurysm clips, or metal in the eyes
  • Other MRI exclusions as determined by the MRI facility
  • Unstable heart conditions (heart rate below 45/min, low blood pressure below 90 mmHg)
  • Claustrophobia
  • Significant hearing loss or tinnitus
  • Acute mental disorders requiring treatment
  • Current pregnancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Single visit

Participants undergo a standardized, non-invasive cardiac magnetic resonance (CMR) imaging exam along with questionnaire-based medical history and laboratory testing using telemedically-supervised mobile diagnostic units.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Deutsches Herzzentrum der Charité

Berlin, Germany, 13353

Actively Recruiting

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Research Team

P

Prof. Dr. Sebastian Kelle

D

Dr. Gisela Thiede

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Echocardiographic Features Beyond Ejection Fraction and Associated Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction.

Anthony E Peters, Robert M Clare, Karen Chiswell...

https://pubmed.ncbi.nlm.nih.gov/37192287

Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association.

Paul A Heidenreich, Nancy M Albert, Larry A Allen...

https://pubmed.ncbi.nlm.nih.gov/23616602

Progression of Preclinical Heart Failure: A Description of Stage A and B Heart Failure in a Community Population.

Kathleen A Young, Christopher G Scott, Richard J Rodeheffer...

https://pubmed.ncbi.nlm.nih.gov/33951931

A simplified approach to discriminate between healthy subjects and patients with heart failure using cardiac magnetic resonance myocardial deformation imaging.

Undine Ella Witt, Maximilian Leo Müller, Rebecca Elisabeth Beyer...

https://pubmed.ncbi.nlm.nih.gov/39318449

Interpreting the Kansas City Cardiomyopathy Questionnaire in Clinical Trials and Clinical Care: JACC State-of-the-Art Review.

John A Spertus, Philip G Jones, Alexander T Sandhu...

https://pubmed.ncbi.nlm.nih.gov/33183512

Impact of Patient Visualization of Cardiovascular Images on Modification of Cardiovascular Risk Factors: Systematic Review and Meta-Analysis.

Kristyn Whitmore, Zhen Zhou, Niamh Chapman...

https://pubmed.ncbi.nlm.nih.gov/37227327