"HerzCheck" - Detection of Early Heart Failure Using Telemedicine in Structurally Weak Regions

NCT05122793 | Active Not Recruiting

• 1 other identifier: EA4/204/20
• Study Type: interventional
• Target: 4,509
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to provide a basis for decision-making for the improved medical care of patients with asymptomatic heart failure, especially in structurally weak regions.

Conditions

Heart Failure with Preserved Ejection Fraction

Keywords

Prevention; Heart failure; HFpEF; Asymptomatic; Cardiology; Rural Region; Germany; CMR; Cardiac Magnetic Resonance; HFrEF; Diastolic Dysfunction; Strain; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Improved GLS

  Improved GLS at after one year compared to baseline.

  12 months

Secondary Outcomes (19)

• Body weight in kilograms and body height in meters will be aggregated to report BMI in kg/m^2

  12 months

• Systolic and diastolic blood pressure in mmHg

  12 months

• Heart rate in BPM

  12 months

• Quality of life questionnaire 1 in Likert scale

  12 months

• Quality of life questionnaire 2 in Likert scale

  12 months

Study Arms (2)

Prevention Group

EXPERIMENTAL

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).

Behavioral: Prevention offer

Control Group

NO INTERVENTION

The control group receives the current standard treatment according to the valid guidelines (Standard of Care = SoC).

Interventions

Prevention offer BEHAVIORAL

Improvement of outcomes through lifestyle changes and improved health literacy

Prevention Group

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoking
• Hypercholesterolaemia
• Arterial hypertension
• Obesity
• Chronic diabetes mellitus
• Chronic kidney disease
• Health insurance

You may not qualify if:

• Previously diagnosed Heart Failure

Sponsors & Collaborators

• German Heart Institute: lead
• medneo GmbH, Germany: collaborator
• Medical Statistics, University Medicine of Goettingen: collaborator
• University of Cologne: collaborator
• University Hospital Heidelberg: collaborator
• AOK Nordost: collaborator
• Herz- und Gefaesszentrum Bad Bevensen: collaborator

Study Sites (1)

Deutsches Herzzentrum der Charité

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (17)

• 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.

  PMID: 28264868 BACKGROUND

• 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.

  PMID: 29181827 BACKGROUND

• 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.

  PMID: 16972704 BACKGROUND

• 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.

  PMID: 31832979 BACKGROUND

• 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.

  PMID: 31504418 BACKGROUND

• 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.

  PMID: 27206819 BACKGROUND

• 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.

  PMID: 29248650 BACKGROUND

• 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.

  PMID: 31123926 BACKGROUND

• 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.

  PMID: 31712641 BACKGROUND

• 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.

  PMID: 30458579 BACKGROUND

• 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.

  PMID: 31497854 BACKGROUND

• 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.

  PMID: 32602663 BACKGROUND

• 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.

  PMID: 31694263 BACKGROUND

• 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.

  PMID: 29350345 BACKGROUND

• 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.

  PMID: 23313577 BACKGROUND

• 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.

  PMID: 31103586 BACKGROUND

• 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.

  PMID: 39824461 DERIVED

Related Links

• Project Website in German language

MeSH Terms

Conditions

Heart Failure; Sprains and Strains

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Sebastian Kelle, MD

  Deutsches Herzzentrum der Charité

  PRINCIPAL INVESTIGATOR

• Diana Graja

  AOK Nordost

  STUDY CHAIR

• Daniel Sievritts

  medneo GmbH

  STUDY CHAIR

• Tim Friede, PhD

  Medical Statistics, University Medicine of Goettingen

  STUDY CHAIR

• Stephanie Stock, MD

  University of Cologne

  STUDY CHAIR

• Norbert Frey, MD

  University Hospital Heidelberg

  STUDY CHAIR

• Bjoern Remppis, MD

  Herz- und Gefaesszentrum Bad Bevensen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The attending physician who examines the patients is blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sebastian Kelle (MD)

Model Details: The present study is a prospective, monocentric, randomised controlled trial with stratification and blinded assessment of the endpoint (Prospective Randomised Open Blinded Endpoint (PROBE) design).

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 17, 2021
• Study Start: June 21, 2021
• Primary Completion: April 5, 2023
• Study Completion (Estimated): September 30, 2034
• Last Updated: March 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)