Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR
NCT ID: NCT07185100
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2025-09-13
2035-12-31
Brief Summary
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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).
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Detailed Description
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Within the framework of the study, 450 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 (\> 500.000 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 exclusively via telemedicine 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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Diagnosed heart failure or previously detected reduced ejection fraction
* 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
40 Years
69 Years
ALL
No
Sponsors
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Medical Statistics, University Medicine of Goettingen
OTHER
AstraZeneca
INDUSTRY
German Heart Institute
OTHER
Responsible Party
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Sebastian Kelle
Dr. Sebastian Kelle (MD)
Principal Investigators
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Sebastian Kelle, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum der Charité
Locations
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Deutsches Herzzentrum der Charité
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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NVL Chronische Herzinsuffizienz Langfassung - Version 4.0, 2023
Spertus JA, Jones PG, Sandhu AT, Arnold SV. Interpreting the Kansas City Cardiomyopathy Questionnaire in Clinical Trials and Clinical Care: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Nov 17;76(20):2379-2390. doi: 10.1016/j.jacc.2020.09.542.
Leotsinidis M, Alexopoulos A, Schinas V, Kardara M, Kondakis X. Plasma retinol and tocopherol levels in greek elderly population from an urban and a rural area: associations with the dietary habits. Eur J Epidemiol. 2000;16(11):1009-16. doi: 10.1023/a:1010895227352.
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Yang H, Negishi K, Wang Y, Nolan M, Marwick TH. Imaging-Guided Cardioprotective Treatment in a Community Elderly Population of Stage B Heart Failure. JACC Cardiovasc Imaging. 2017 Mar;10(3):217-226. doi: 10.1016/j.jcmg.2016.11.015.
Whitmore K, Zhou Z, Chapman N, Huynh Q, Magnussen CG, Sharman JE, Marwick TH. Impact of Patient Visualization of Cardiovascular Images on Modification of Cardiovascular Risk Factors: Systematic Review and Meta-Analysis. JACC Cardiovasc Imaging. 2023 Aug;16(8):1069-1081. doi: 10.1016/j.jcmg.2023.03.007. Epub 2023 May 24.
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Hood SR, Giazzon AJ, Seamon G, Lane KA, Wang J, Eckert GJ, Tu W, Murray MD. Association Between Medication Adherence and the Outcomes of Heart Failure. Pharmacotherapy. 2018 May;38(5):539-545. doi: 10.1002/phar.2107. Epub 2018 Apr 30.
Patchell RA, Posner JB. Neurologic complications of systemic cancer. Neurol Clin. 1985 Nov;3(4):729-50.
Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. No abstract available.
Haji K, Huynh Q, Wong C, Stewart S, Carrington M, Marwick TH. Improving the Characterization of Stage A and B Heart Failure by Adding Global Longitudinal Strain. JACC Cardiovasc Imaging. 2022 Aug;15(8):1380-1387. doi: 10.1016/j.jcmg.2022.03.007. Epub 2022 May 11.
Potter E, Stephenson G, Harris J, Wright L, Marwick TH. Screening-guided spironolactone treatment of subclinical left ventricular dysfunction for heart failure prevention in at-risk patients. Eur J Heart Fail. 2022 Apr;24(4):620-630. doi: 10.1002/ejhf.2428. Epub 2022 Jan 27.
Chistoni GC. [Some problems posed by double-blind investigation of psychotropic drugs: clinical trial of Nobrium Roche]. Schweiz Arch Neurol Neurochir Psychiatr. 1971;108(2):309-15. No abstract available. French.
Komajda M, Cowie MR, Tavazzi L, Ponikowski P, Anker SD, Filippatos GS; QUALIFY Investigators. Physicians' guideline adherence is associated with better prognosis in outpatients with heart failure with reduced ejection fraction: the QUALIFY international registry. Eur J Heart Fail. 2017 Nov;19(11):1414-1423. doi: 10.1002/ejhf.887. Epub 2017 Apr 30.
Related Links
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Datenbank der Gesundheitsberichterstattung (GBE) der Länder
NHS Diagnostic Waiting Times and Activity Statistical Report
Other Identifiers
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WE-CARE-HF-CMR
Identifier Type: -
Identifier Source: org_study_id
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