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

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

"HerzCheck" - Erkennung Und Prävention Einer frühen Herzinsuffizienz Mittels Telemedizinischer Verfahren in Strukturschwachen Regionen

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05122793
• Other study ID #: EA4/204/20
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: German Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, 4,500 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4500
• Est. completion date: April 2024
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

• Smoking
• Hypercholesterolaemia
• Arterial hypertension
• Adiposity
• Diabetes
• Kidney Insufficiency
• Health insurance

Exclusion Criteria:

• HFrEF
• MRI-exclusion criteria

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Behavioral:
• Prevention offer
Improvement of outcomes through lifestyle changes and improved health literacy

Locations

Country	Name	City	State
Germany	German Heart Institute	Berlin

Sponsors (7)

Lead Sponsor	Collaborator
German Heart Institute	AOK Nordost, Herz- und Gefaesszentrum Bad Bevensen, Medical Statistics, University Medicine of Goettingen, medneo GmbH, Germany, University Hospital Heidelberg, University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (16)

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. — View 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. — View 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. Erratum In: Eur Heart J. 2020 Dec 1;41(45):4317. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4255. — View 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. — View 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. Erratum In: Eur Heart J. 2016 Dec 30;: — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved GLS	Improved GLS at after one year compared to baseline.	12 months
Secondary	Body weight in kilograms and body height in meters will be aggregated to report BMI in kg/m^2	BMI at baseline compared to after one year.	12 months
Secondary	Systolic and diastolic blood pressure in mmHg	blood pressure at baseline compared to after one year.	12 months
Secondary	Heart rate in BPM	heart rate at baseline compared to after one year.	12 months
Secondary	Quality of life questionnaire 1 in Likert scale	Quality of life at after one year compared to baseline. Min. value: 0, max value: 3; higher score: better outcome.	12 months
Secondary	Quality of life questionnaire 2 in Likert scale	Quality of life at after one year compared to baseline. Min. value: 1, max value: 5; higher score: depending on question.	12 months
Secondary	laboratory parameters: Iron, transferrin and creatinine	laboratory parameters in µmol/l at baseline compared to after one year.	12 months
Secondary	laboratory parameters: Sodium, potassium, chloride, total cholesterol, triglycerides, HDL cholesterole, LDL cholesterole, hemoglobin and MCHC	laboratory parameters in mmol/l at baseline compared to after one year.	12 months
Secondary	laboratory parameters: White cells and platelets	laboratory parameters in GPt/l at baseline compared to after one year.	12 months
Secondary	laboratory parameters: MCV	laboratory parameter in fl at baseline compared to after one year.	12 months
Secondary	laboratory parameters: RDW-SD	laboratory parameter in fl at baseline compared to after one year.	12 months
Secondary	laboratory parameter: HbA1c	laboratory parameter in mmol/mol at baseline compared to after one year.	12 months
Secondary	laboratory parameter: red cells	laboratory parameter in TPt/l at baseline compared to after one year.	12 months
Secondary	laboratory parameter: MCH	laboratory parameter in fmol at baseline compared to after one year.	12 months
Secondary	laboratory parameter: hematocrit	laboratory parameter in l/l at baseline compared to after one year.	12 months
Secondary	laboratory parameter: NT-proBNP	laboratory parameter in pmol/l at baseline compared to after one year.	12 months
Secondary	laboratory parameter: transferrin saturation	laboratory parameter in % at baseline compared to after one year.	12 months
Secondary	laboratory parameter: ferritin	laboratory parameter in µg/l at baseline compared to after one year.	12 months
Secondary	hospitalisations of cardiac origin, arrhythmias or death	Appearance of hospitalisations of cardiac origin, arrhythmias or death	12 months

External Links

•   Project Website in German language