Clinical trial NCT05122793: "HerzCheck" - Detection of Early Heart Failure Using Telemedicine in Structurally Weak Regions
Official title: "HerzCheck" - Erkennung Und Prävention Einer Frühen Herzinsuffizienz Mittels Telemedizinischer Verfahren in Strukturschwachen Regionen
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: medneo GmbH, Germany
name: Medical Statistics, University Medicine of Goettingen
name: University of Cologne
name: University Hospital Heidelberg
name: AOK Nordost
name: Herz- und Gefaesszentrum Bad Bevensen
First posted: 2021-11-17
Enrollment: 4509
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Detailed description: The aim of the study is the early detection of asymptomatic heart failure with a quality-assured cardiac screening MRI in the population in structurally weak regions and especially in patients with risk factors for the occurrence of heart failure. The diagnosis is followed by early initiation of appropriate therapeutic measures to improve the prognosis of the affected patients, avoid hospitalisations and save therapy costs, and is combined with recommended measures to minimise risk factors for the development of heart failure. The project includes a prospective, monocentric, randomised controlled clinical trial with blinded assessment of the endpoint (PROBE design). Within the scope of the study, 4,509 patients aged between 40 and 69 years who have characteristic risk factors for the development of heart failure were examined using a mobile cardiac screening MRI in the federal states of Brandenburg and Mecklenburg-Western Pomerania within Germany.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previously diagnosed Heart Failure
* MRI-exclusion criteria

Primary outcomes:
measure: Improved GLS
timeFrame: 12 months
Secondary outcomes:
measure: Body weight in kilograms and body height in meters will be aggregated to report BMI in kg/m^2
timeFrame: 12 months
measure: Systolic and diastolic blood pressure in mmHg
timeFrame: 12 months
measure: Heart rate in BPM
timeFrame: 12 months
measure: Quality of life questionnaire 1 in Likert scale
timeFrame: 12 months
measure: Quality of life questionnaire 2 in Likert scale
timeFrame: 12 months
measure: laboratory parameters: Iron, transferrin and creatinine
timeFrame: 12 months
measure: laboratory parameters: Sodium, potassium, chloride, total cholesterol, triglycerides, HDL cholesterole, LDL cholesterole, hemoglobin and MCHC
timeFrame: 12 months
measure: laboratory parameters: White cells and platelets
timeFrame: 12 months
measure: laboratory parameters: MCV
timeFrame: 12 months
measure: laboratory parameters: RDW-SD
timeFrame: 12 months
measure: laboratory parameter: HbA1c
timeFrame: 12 months
measure: laboratory parameter: red cells
timeFrame: 12 months
measure: laboratory parameter: MCH
timeFrame: 12 months
measure: laboratory parameter: hematocrit
timeFrame: 12 months
measure: laboratory parameter: NT-proBNP
timeFrame: 12 months
measure: laboratory parameter: transferrin saturation
timeFrame: 12 months
measure: laboratory parameter: ferritin
timeFrame: 12 months
measure: hospitalisations of cardiac origin, arrhythmias or death
timeFrame: 12 months
measure: Laboratory parameters: urine albumin-creatinine ratio
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
Study officials:
affiliation: Deutsches Herzzentrum der Charité
name: Sebastian Kelle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOK Nordost
name: Diana Graja
role: STUDY_CHAIR
affiliation: medneo GmbH
name: Daniel Sievritts
role: STUDY_CHAIR
affiliation: Medical Statistics, University Medicine of Goettingen
name: Tim Friede, PhD
role: STUDY_CHAIR
affiliation: University of Cologne
name: Stephanie Stock, MD
role: STUDY_CHAIR
affiliation: University Hospital Heidelberg
name: Norbert Frey, MD
role: STUDY_CHAIR
affiliation: Herz- und Gefaesszentrum Bad Bevensen
name: Bjoern Remppis, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.