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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Philips Healthcare | INDUSTRY |
| Deutsches Herzzentrum der Charité, Berlin | UNKNOWN |
| German Heart Center Foundation |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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% | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of chronic kidney disease (CKD) | CKD is defined as eGFR < 60% | at baseline |
| Adherence to therapy | Assessed using the MARS-10 questionnaire |
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Inclusion Criteria:
Asymptomatic subjects with:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Sebastian Kelle | Contact | +493045931182 | sebastian.kelle@dhzc-charite.de | |
| Dr. Gisela Thiede | Contact | +4915209192843 | gisela.thiede@dhzc-charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Sebastian Kelle, Prof. Dr. | Deutsches Herzzentrum der Charité | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum der Charité | Recruiting | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37192287 | Background | 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. | |
| 23616602 |
| Label | URL |
|---|---|
| homepage of the trial: WE-CARE-HF-CMR | View source |
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| UNKNOWN |
| Nationale Herzallianz (NHA) | UNKNOWN |
| Deutsche Herzstiftung | UNKNOWN |
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two tubes of blood
| 1, 5 years and 10 years later |
| 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. |
| 33951931 | Background | 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. |
| 27397013 | Background | 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. |
| 39318449 | Background | 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. |
| 35862175 | Background | 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. |
| Background | NVL Chronische Herzinsuffizienz Langfassung - Version 4.0, 2023 |
| 33183512 | Background | 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. |
| 28279368 | Background | 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. |
| 37227327 | Background | 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. |
| 29600819 | Background | 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. |
| 37797885 | Background | 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. |
| 35926896 | Background | 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. |
| 35014128 | Background | 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. |
| 28463464 | Background | 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. |
| 42142740 | Derived | 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. |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D006333 | Heart Failure |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014947 | Wounds and Injuries |
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