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

NCT05520307 | Unknown

• 1 other identifier: VentriJect Gentofte Study
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SeismoFit; CPET; Heart Failure; VO2max assessment; Ischemic heart disease; Seismocardiography

Outcome Measures

Primary Outcomes (1)

• Validity of SeismoFit VO2max estimation in HF and IHD patients

  Assessment of VO2max at rest with SeismoFit and with a gold standard CPET. The validity of the SeismoFit will be based on difference and agreement between the two test methods for both hart failure patients and patients with ischemic heart disease.

  1 day

Secondary Outcomes (2)

• Detection of change in VO2max using SeismoFit

  4-5 month

• Reliability of the SeimoFit VO2max estimation

  7 days

Study Arms (2)

HF

Patients with heart failure.

IHD

Patients with ischemic heart disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure: HFrEF (LVEF \< 40%) and NYHA I-III. And Patients with Ischemic heart disease

You may qualify if:

• Fulfilling the guidelines for rehabilitation sat out by the Danish Society of Cardiology.
• Approved for exercise testing on a cycle ergometer by a specialized doctor in cardiology.

You may not qualify if:

• Absolute contraindications with training
• Conditions that prevent maximal exercise testing assess by a specialized doctor in cardiology.

Sponsors & Collaborators

• University of Copenhagen: lead
• Herlev and Gentofte Hospital: collaborator
• VentriJect ApS: collaborator

Study Sites (1)

Herlev and Gentofte Hospital

Gentofte Municipality, 2900, Denmark

RECRUITING

Related Publications (1)

• Hansen MT, Hashiba M, Nielsen SK, Petersen CS, Saederup RG, Schmidt SE, Wolsk E, Helge JW, Lamberts M. Non-exercise estimation of peak oxygen uptake in patients with ischaemic heart disease and heart failure using seismocardiography. Eur Heart J Digit Health. 2025 Sep 2;7(1):ztaf095. doi: 10.1093/ehjdh/ztaf095. eCollection 2026 Jan.

  PMID: 41574039 DERIVED

MeSH Terms

Conditions

Heart Failure; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jørn W Helge, Professor

  Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jørn W Helge, Professor

CONTACT

+45 28757506; jhelge@sund.ku.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: December 16, 2023
• Primary Completion: April 1, 2024
• Study Completion: August 31, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)