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Heart Failure with Preserved Ejection FractionNCT05122793

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

A study testing Prevention offer in people with Heart Failure with Preserved Ejection Fraction, run by German Heart Institute at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 69 years
What is being tested?
Prevention offer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,509 participants
Where
1 siteGermany
Study dates
21 Jun 2021to 30 Sep 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Previously diagnosed Heart Failure
  • MRI-exclusion criteria

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Deutsches Herzzentrum der Charité

    Berlin, State of Berlin, 13353

Other trials in Germany

About this study

Official title: "HerzCheck" - Erkennung Und Prävention Einer Frühen Herzinsuffizienz Mittels Telemedizinischer Verfahren in Strukturschwachen Regionen

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.

Read the 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.

Being tested
Prevention offer
Keywords
Prevention, Heart failure, HFpEF, Asymptomatic, Cardiology, Rural Region, Germany, CMR, Cardiac Magnetic Resonance, HFrEF, Diastolic Dysfunction, Strain, Telemedicine
Medical subject headings
Heart Failure, Sprains and Strains

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prevention offerBehavioural

    Improvement of outcomes through lifestyle changes and improved health literacy

Study groups in NCT05122793
Study groupRoleWhat they receive
Prevention GroupExperimentalIn 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).
Receives: Behavioral: Prevention offer
Control GroupNo interventionThe control group receives the current standard treatment according to the valid guidelines (Standard of Care = SoC).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improved GLS

    Improved GLS at after one year compared to baseline.

    Measured: 12 months

Secondary outcomes (19)

  1. 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.

    Measured: 12 months

  2. Systolic and diastolic blood pressure in mmHg

    blood pressure at baseline compared to after one year.

    Measured: 12 months

  3. Heart rate in BPM

    heart rate at baseline compared to after one year.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. laboratory parameters: Iron, transferrin and creatinine

    laboratory parameters in µmol/l at baseline compared to after one year.

    Measured: 12 months

  7. 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.

    Measured: 12 months

  8. laboratory parameters: White cells and platelets

    laboratory parameters in GPt/l at baseline compared to after one year.

    Measured: 12 months

  9. laboratory parameters: MCV

    laboratory parameter in fl at baseline compared to after one year.

    Measured: 12 months

  10. laboratory parameters: RDW-SD

    laboratory parameter in fl at baseline compared to after one year.

    Measured: 12 months

  11. laboratory parameter: HbA1c

    laboratory parameter in mmol/mol at baseline compared to after one year.

    Measured: 12 months

  12. laboratory parameter: red cells

    laboratory parameter in TPt/l at baseline compared to after one year.

    Measured: 12 months

  13. laboratory parameter: MCH

    laboratory parameter in fmol at baseline compared to after one year.

    Measured: 12 months

  14. laboratory parameter: hematocrit

    laboratory parameter in l/l at baseline compared to after one year.

    Measured: 12 months

  15. laboratory parameter: NT-proBNP

    laboratory parameter in pmol/l at baseline compared to after one year.

    Measured: 12 months

  16. laboratory parameter: transferrin saturation

    laboratory parameter in % at baseline compared to after one year.

    Measured: 12 months

  17. laboratory parameter: ferritin

    laboratory parameter in µg/l at baseline compared to after one year.

    Measured: 12 months

  18. hospitalisations of cardiac origin, arrhythmias or death

    Appearance of hospitalisations of cardiac origin, arrhythmias or death

    Measured: 12 months

  19. Laboratory parameters: urine albumin-creatinine ratio

    UACR, calculated from albumin and creatinine in urine in mmol/l at baseline compared to after one year.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2021
  2. Study start21 Jun 2021
  3. Primary completion5 Apr 2023
  4. Study completion30 Sep 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Investigator
Enrolment
4,509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05122793
Sponsor's protocol ID
EA4/204/20
Status last verified
Oct 2024
First submitted
21 Oct 2021
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not planned to make IPD available to other researchers.

Publications

  • 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.

    PubMed 28264868

  • 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.

    PubMed 29181827

  • 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.

    PubMed 16972704

  • 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.

    PubMed 31832979

  • 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.

    PubMed 31504418

  • 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.

    PubMed 27206819

  • 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.

    PubMed 29248650

  • 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.

    PubMed 31123926

  • 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.

    PubMed 31712641

  • 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.

    PubMed 30458579

  • 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.

    PubMed 31497854

  • 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.

    PubMed 32602663

  • 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.

    PubMed 31694263

  • 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.

    PubMed 29350345

  • 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.

    PubMed 23313577

Questions about this trial

What is this clinical trial studying?

A study testing Prevention offer in people with Heart Failure with Preserved Ejection Fraction, run by German Heart Institute at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improved GLS (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05122793, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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