"HerzCheck" - Detection of Early Heart Failure Using Telemedicine in Structurally Weak Regions
NCT ID: NCT05122793
Last Updated: 2025-03-06
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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ACTIVE_NOT_RECRUITING
NA
4509 participants
INTERVENTIONAL
2021-06-21
2034-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Prevention Group
In addition to the usual treatment (SoC), the prevention group receives an innovative prevention offer tailored to the severity of the heart failure (telemedical connection via health app as well as additional therapy recommendations).
Prevention offer
Improvement of outcomes through lifestyle changes and improved health literacy
Control Group
The control group receives the current standard treatment according to the valid guidelines (Standard of Care = SoC).
No interventions assigned to this group
Interventions
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Prevention offer
Improvement of outcomes through lifestyle changes and improved health literacy
Eligibility Criteria
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Inclusion Criteria
* Hypercholesterolaemia
* Arterial hypertension
* Obesity
* Chronic diabetes mellitus
* Chronic kidney disease
* Health insurance
Exclusion Criteria
40 Years
69 Years
ALL
No
Sponsors
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medneo GmbH, Germany
UNKNOWN
Medical Statistics, University Medicine of Goettingen
OTHER
University of Cologne
OTHER
University Hospital Heidelberg
OTHER
AOK Nordost
INDUSTRY
Herz- und Gefaesszentrum Bad Bevensen
OTHER
German Heart Institute
OTHER
Responsible Party
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Sebastian Kelle
Dr. Sebastian Kelle (MD)
Principal Investigators
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Sebastian Kelle, MD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum der Charité
Diana Graja
Role: STUDY_CHAIR
AOK Nordost
Daniel Sievritts
Role: STUDY_CHAIR
medneo GmbH
Tim Friede, PhD
Role: STUDY_CHAIR
Medical Statistics, University Medicine of Goettingen
Stephanie Stock, MD
Role: STUDY_CHAIR
University of Cologne
Norbert Frey, MD
Role: STUDY_CHAIR
University Hospital Heidelberg
Bjoern Remppis, MD
Role: STUDY_CHAIR
Herz- und Gefaesszentrum Bad Bevensen
Locations
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Deutsches Herzzentrum der Charité
Berlin, State of Berlin, Germany
Countries
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References
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Biering-Sorensen T, Biering-Sorensen SR, Olsen FJ, Sengelov M, Jorgensen PG, Mogelvang R, Shah AM, Jensen JS. Global Longitudinal Strain by Echocardiography Predicts Long-Term Risk of Cardiovascular Morbidity and Mortality in a Low-Risk General Population: The Copenhagen City Heart Study. Circ Cardiovasc Imaging. 2017 Mar;10(3):e005521. doi: 10.1161/CIRCIMAGING.116.005521.
Liu B, Dardeer AM, Moody WE, Hayer MK, Baig S, Price AM, Leyva F, Edwards NC, Steeds RP. Reference ranges for three-dimensional feature tracking cardiac magnetic resonance: comparison with two-dimensional methodology and relevance of age and gender. Int J Cardiovasc Imaging. 2018 May;34(5):761-775. doi: 10.1007/s10554-017-1277-x. Epub 2017 Nov 27.
Friede T, Kieser M. Sample size recalculation in internal pilot study designs: a review. Biom J. 2006 Aug;48(4):537-55. doi: 10.1002/bimj.200510238.
Huber A, Oldridge N, Benzer W, Saner H, Hofer S. Validation of the German HeartQoL: a short health-related quality of life questionnaire for cardiac patients. Qual Life Res. 2020 Apr;29(4):1093-1105. doi: 10.1007/s11136-019-02384-6. Epub 2019 Dec 12.
Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
Rademakers F, Nagel E. Is Global Longitudinal Strain a Superior Parameter for Predicting Outcome After Myocardial Infarction? JACC Cardiovasc Imaging. 2018 Oct;11(10):1458-1460. doi: 10.1016/j.jcmg.2017.11.005. Epub 2017 Dec 13. No abstract available.
Schneider JE, Stojanovic I. Economic evaluation of cardiac magnetic resonance with fast-SENC in the diagnosis and management of early heart failure. Health Econ Rev. 2019 May 23;9(1):13. doi: 10.1186/s13561-019-0229-7.
Tanacli R, Hashemi D, Lapinskas T, Edelmann F, Gebker R, Pedrizzetti G, Schuster A, Nagel E, Pieske B, Dungen HD, Kelle S. Range Variability in CMR Feature Tracking Multilayer Strain across Different Stages of Heart Failure. Sci Rep. 2019 Nov 11;9(1):16478. doi: 10.1038/s41598-019-52683-8.
Unkel S, Amiri M, Benda N, Beyersmann J, Knoerzer D, Kupas K, Langer F, Leverkus F, Loos A, Ose C, Proctor T, Schmoor C, Schwenke C, Skipka G, Unnebrink K, Voss F, Friede T. On estimands and the analysis of adverse events in the presence of varying follow-up times within the benefit assessment of therapies. Pharm Stat. 2019 Mar;18(2):166-183. doi: 10.1002/pst.1915. Epub 2018 Nov 20.
Cosentino F, Grant PJ, Aboyans V, Bailey CJ, Ceriello A, Delgado V, Federici M, Filippatos G, Grobbee DE, Hansen TB, Huikuri HV, Johansson I, Juni P, Lettino M, Marx N, Mellbin LG, Ostgren CJ, Rocca B, Roffi M, Sattar N, Seferovic PM, Sousa-Uva M, Valensi P, Wheeler DC; ESC Scientific Document Group. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020 Jan 7;41(2):255-323. doi: 10.1093/eurheartj/ehz486. No abstract available.
Chopra VK, Anker SD. Anaemia, iron deficiency and heart failure in 2020: facts and numbers. ESC Heart Fail. 2020 Oct;7(5):2007-2011. doi: 10.1002/ehf2.12797. Epub 2020 Jun 30.
Doeblin P, Hashemi D, Tanacli R, Lapinskas T, Gebker R, Stehning C, Motzkus LA, Blum M, Tahirovic E, Dordevic A, Kraft R, Zamani SM, Pieske B, Edelmann F, Dungen HD, Kelle S. CMR Tissue Characterization in Patients with HFmrEF. J Clin Med. 2019 Nov 5;8(11):1877. doi: 10.3390/jcm8111877.
Fischer F, Gibbons C, Coste J, Valderas JM, Rose M, Leplege A. Measurement invariance and general population reference values of the PROMIS Profile 29 in the UK, France, and Germany. Qual Life Res. 2018 Apr;27(4):999-1014. doi: 10.1007/s11136-018-1785-8. Epub 2018 Jan 19.
Gaggin HK, Januzzi JL Jr. Biomarkers and diagnostics in heart failure. Biochim Biophys Acta. 2013 Dec;1832(12):2442-50. doi: 10.1016/j.bbadis.2012.12.014. Epub 2013 Jan 9.
Pedrizzetti G, Lapinskas T, Tonti G, Stoiber L, Zaliunas R, Gebker R, Pieske B, Kelle S. The Relationship Between EF and Strain Permits a More Accurate Assessment of LV Systolic Function. JACC Cardiovasc Imaging. 2019 Sep;12(9):1893-1895. doi: 10.1016/j.jcmg.2019.03.019. Epub 2019 May 15. No abstract available.
Kelle S, Nolden AC, Muller ML, Beyer RE, Steen H, Remppis BA, Wieditz J, Kentenich H, Tuit A, Cvetkovic M, Witt UE, Andre F, Schmidt S, Huppertz A, Simic D, Muller D, Shukri A, Issing M, Glardon A, Reber KC, Landmesser U, Frey N, Pieske B, Stock S, Falk V, Friede T, Thiede G. Rationale and design of the HERZCHECK trial: Detection of early heart failure using telemedicine and cardiovascular magnetic resonance in structurally weak regions (NCT05122793). J Cardiovasc Magn Reson. 2025 Summer;27(1):101841. doi: 10.1016/j.jocmr.2025.101841. Epub 2025 Jan 15.
Related Links
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Project Website in German language
Other Identifiers
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EA4/204/20
Identifier Type: -
Identifier Source: org_study_id
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