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RecruitingNCT07185100WE-CARE-HF-CMRUpdated Apr 1, 2026

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

An observational study in Heart Failure With Preserved Ejection Fraction (HFPEF), Renal Dysfunction and Stage B Heart Failure, sponsored by German Heart Institute. Recruiting at 1 site in Germany. Open to participants aged 40 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by German Heart Institute · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
600
Ages
40 Years to 69 Years
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Heart Failure With Preserved Ejection Fraction (HFPEF)
  • Renal Dysfunction
  • Stage B Heart Failure

Keywords

  • Prevention
  • Heart failure
  • HFpEF
  • Asymptomatic
  • Cardiology
  • Urban area
  • Germany
  • CMR
  • Cardiac Magnetic Resonance
  • HFrEF
  • Diastolic Dysfunction
  • Strain
  • mobile
  • GLS
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In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 600 is above the median of 149 across 394 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

German Heart Institute is the lead sponsor of 25 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 69 Years
Sexes eligible
All
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.

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

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Prevalence of asymptomatic pre-heart failure (stage B) in an urban population

    Asymptomatic pre-heart failure (stage B) is defined as CMR-derived global longitudinal strain (GLS) ≥ -15%

    Time frame: at baseline

Secondary outcomes

  1. Prevalence of chronic kidney disease (CKD)

    CKD is defined as eGFR \< 60%

    Time frame: at baseline

  2. Adherence to therapy

    Assessed using the MARS-10 questionnaire

    Time frame: 1, 5 years and 10 years later

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Peters AE, Clare RM, Chiswell K, Felker GM, Kelsey A, Mentz R, DeVore AD. Echocardiographic Features Beyond Ejection Fraction and Associated Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction. Circ Heart Fail. 2023 May;16(5):e010252. doi: 10.1161/CIRCHEARTFAILURE.122.010252. Epub 2023 May 16. PubMed 37192287 ↗
  • Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24. PubMed 23616602 ↗
  • Young KA, Scott CG, Rodeheffer RJ, Chen HH. Progression of Preclinical Heart Failure: A Description of Stage A and B Heart Failure in a Community Population. Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007216. doi: 10.1161/CIRCOUTCOMES.120.007216. Epub 2021 May 6. PubMed 33951931 ↗
  • Unverzagt S, Meyer G, Mittmann S, Samos FA, Unverzagt M, Prondzinsky R. Improving Treatment Adherence in Heart Failure. Dtsch Arztebl Int. 2016 Jun 24;113(25):423-30. doi: 10.3238/arztebl.2016.0423. PubMed 27397013 ↗
  • Witt UE, Muller ML, Beyer RE, Wieditz J, Salem S, Hashemi D, Chen W, Cvetkovic M, Nolden AC, Doeblin P, Blum M, Thiede G, Huppertz A, Steen H, Remppis BA, Falk V, Friede T, Kelle S. A simplified approach to discriminate between healthy subjects and patients with heart failure using cardiac magnetic resonance myocardial deformation imaging. Eur Heart J Imaging Methods Pract. 2024 Sep 12;2(3):qyae093. doi: 10.1093/ehjimp/qyae093. eCollection 2024 Jul. PubMed 39318449 ↗
  • Young KA, Scott CG, Rodeheffer RJ, Chen HH. Incidence of Preclinical Heart Failure in a Community Population. J Am Heart Assoc. 2022 Aug 2;11(15):e025519. doi: 10.1161/JAHA.122.025519. Epub 2022 Jul 20. PubMed 35862175 ↗
  • 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. PubMed 33183512 ↗
  • 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. PubMed 28279368 ↗
  • 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. PubMed 37227327 ↗
  • 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. PubMed 29600819 ↗
  • 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. PubMed 37797885 ↗
  • 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. PubMed 35926896 ↗
  • 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. PubMed 35014128 ↗
  • 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. PubMed 28463464 ↗
  • Li JJ, Thiede G, Gotze C, Exarchos V, Meuwly C, Werhahn SM, Beyer RE, Muller ML, Bigvava T, Stehning C, Remppis BA, Wieditz J, Sack S, Heer T, Sroka M, Nagel E, Hays AG, Duvigneau G, Blankenberg S, Steen H, Frey N, Baldus S, Seuthe K, Lorbach R, Rodicker F, Scharf S, Hilgendorf I, Landmesser U, Friede T, Falk V, Doeblin P, Kelle S. Design and rationale of the WE-CARE-HF-CMR trial: Cardiorenal care on wheels for asymptomatic heart failure patients (NCT07185100). J Cardiovasc Magn Reson. 2026 May 15;28(2):102745. doi: 10.1016/j.jocmr.2026.102745. Online ahead of print. PubMed 42142740 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07185100
Lead sponsor
German Heart Institute
Collaborators
AstraZeneca, Philips Healthcare, Deutsches Herzzentrum der Charité, Berlin, German Heart Center Foundation, Nationale Herzallianz (NHA), Deutsche Herzstiftung
Responsible party
Sebastian Kelle (Dr. Sebastian Kelle (MD), German Heart Institute) — Principal investigator
First posted
Sep 22, 2025
Start date
Sep 13, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2036 (estimated)
Last update
Apr 1, 2026

Study contacts

Prof. Dr. Sebastian Kelle
Contact
sebastian.kelle@dhzc-charite.de
+493045931182
Dr. Gisela Thiede
Contact
gisela.thiede@dhzc-charite.de
+4915209192843
Sebastian Kelle, Prof. Dr.
principal investigator · Deutsches Herzzentrum der Charité

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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