Heart Failure With Preserved Ejection Fraction (HFPEF)WE-CARE-HF-CMRNCT07185100
Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR
An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF) and Renal Dysfunction, run by German Heart Institute at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF), Renal Dysfunction, Stage B Heart Failure
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 13 Sep 2025to 31 Dec 2036
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Sensorineural hearing loss of 30 dB or more and tinnitus
- Acute mental disorders requiring therapy
- In the presence of pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum der Charité
Berlin, 13353
Sebastian Kelle, Prof., MD, +493045931182, sebastian.kelle@dhzc-charite.de
Gisela Thiede, Dr., 0049 1520 9192843, gisela.thiede@dhzc-charite.de
About this study
Official title: A Prospective, Cross-sectional, Nationwide Community-based Observational Study to Determine the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR
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.
- Conditions
- 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
- Medical subject headings
- Renal Insufficiency, Heart Failure, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: at baseline
Secondary outcomes (2)
Prevalence of chronic kidney disease (CKD)
CKD is defined as eGFR < 60%
Measured: at baseline
Adherence to therapy
Assessed using the MARS-10 questionnaire
Measured: 1, 5 years and 10 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start13 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFPEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Philips Healthcare, Deutsches Herzzentrum der Charité, Berlin, German Heart Center Foundation, Nationale Herzallianz (NHA), Deutsche Herzstiftung
- Responsible party
- Principal investigator, Sebastian Kelle, German Heart Institute
- Investigators
- Sebastian Kelle, Prof. Dr., Principal investigator, Deutsches Herzzentrum der Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185100
- Sponsor's protocol ID
- WE-CARE-HF-CMR
- Acronym
- WE-CARE-HF-CMR
- Status last verified
- Mar 2026
- First submitted
- 10 Sep 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37192287Heidenreich 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 23616602Young 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 33951931Unverzagt 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 27397013Witt 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 39318449Young 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 35862175NVL 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 33183512Yang 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 28279368Whitmore 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 37227327Hood 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 29600819Bozkurt 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 37797885Haji 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 35926896Potter 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 35014128Komajda 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