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NCT Number: NCT05122793

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Cardiovascular Diseases Heart Diseases Heart Failure Sprains and Strains Wounds and Injuries

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum der Charité

Berlin, State of Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previously diagnosed Heart Failure
  • MRI-exclusion criteria

Treatment and study plan

Prevention offer

Behavioral

Improvement of outcomes through lifestyle changes and improved health literacy

Primary outcomes

  1. Improved GLS

    Time frame: 12 months

    Improved GLS at after one year compared to baseline.

Secondary outcomes

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

    Time frame: 12 months

    BMI at baseline compared to after one year.

  2. Systolic and diastolic blood pressure in mmHg

    Time frame: 12 months

    blood pressure at baseline compared to after one year.

  3. Heart rate in BPM

    Time frame: 12 months

    heart rate at baseline compared to after one year.

  4. Quality of life questionnaire 1 in Likert scale

    Time frame: 12 months

    Quality of life at after one year compared to baseline. Min. value: 0, max value: 3; higher score: better outcome.

  5. Quality of life questionnaire 2 in Likert scale

    Time frame: 12 months

    Quality of life at after one year compared to baseline. Min. value: 1, max value: 5; higher score: depending on question.

  6. laboratory parameters: Iron, transferrin and creatinine

    Time frame: 12 months

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

  7. laboratory parameters: Sodium, potassium, chloride, total cholesterol, triglycerides, HDL cholesterole, LDL cholesterole, hemoglobin and MCHC

    Time frame: 12 months

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

  8. laboratory parameters: White cells and platelets

    Time frame: 12 months

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

  9. laboratory parameters: MCV

    Time frame: 12 months

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

  10. laboratory parameters: RDW-SD

    Time frame: 12 months

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

  11. laboratory parameter: HbA1c

    Time frame: 12 months

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

  12. laboratory parameter: red cells

    Time frame: 12 months

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

  13. laboratory parameter: MCH

    Time frame: 12 months

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

  14. laboratory parameter: hematocrit

    Time frame: 12 months

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

  15. laboratory parameter: NT-proBNP

    Time frame: 12 months

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

  16. laboratory parameter: transferrin saturation

    Time frame: 12 months

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

  17. laboratory parameter: ferritin

    Time frame: 12 months

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

  18. hospitalisations of cardiac origin, arrhythmias or death

    Time frame: 12 months

    Appearance of hospitalisations of cardiac origin, arrhythmias or death

  19. Laboratory parameters: urine albumin-creatinine ratio

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

German Heart Institute

Other

Collaborators

  • AOK Nordost
  • Herz- und Gefaesszentrum Bad Bevensen
  • Medical Statistics, University Medicine of Goettingen
  • University Hospital Heidelberg
  • University of Cologne
  • medneo GmbH, Germany

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2034
First posted
Nov 17, 2021
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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