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Validity of SeismoFit VO2max Estimation in Patients With Heart Failure or Ischemic Heart Disease

NCT05520307 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2024-01-17

No results posted yet for this study

Summary

Measurement of cardiorespiratory fitness (VO2max) is considered an important tool in risk prediction of cardiovascular disease and overall patient management. The gold standard method for determining VO2max is a maximal cardiopulmonary exercise test (CPET). This requires time, maximal exercise until voluntary exhaustion and expensive equipment and are therefor not always suitable. A non-exercise VO2max prediction model using seismocardiography (SCG) at rest in combination with demographic data has been proposed as an possible alternative. SCG is a non-invasive three-dimensional measurement technique of precordial vibrations caused by the beating heart and can provide information on cardiac performance. New advances in low-weight three-axis accelerometer, signal processing and feature selection has made this methodology attractive in the recent years. VentriJect Aps has develop a medical device for measuring SCG (SeismoFit) together with an cloud solution for signal processing and prediction of VO2max. The validity of the SeismoFit device has previously been assesses in healthy subjects, but not yet in patients.

The aim of this study is therefore to investigate the validity of the SeismoFit VO2max estimation in patients with heart failure (HF) or ischemic heart disease (IHD).

Conditions

  • Cardiopulmonary Exercise Test

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • VentriJect ApS

    collaborator INDUSTRY

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Jørn W Helge, Professor · Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-16
Primary Completion
2024-04-01
Completion
2024-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05520307 on ClinicalTrials.gov