Cardiopulmonary Exercise Test Clinical Trial
Official title:
Validity of SeismoFit VO2max Estimation in Patients With Heart Failure or Ischemic Heart Disease
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).
Status | Recruiting |
Enrollment | 180 |
Est. completion date | August 31, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Absolute contraindications with training - Conditions that prevent maximal exercise testing assess by a specialized doctor in cardiology. |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev and Gentofte Hospital | Gentofte |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Herlev and Gentofte Hospital, VentriJect ApS |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Detection of change in VO2max using SeismoFit | A follow-up test day after meeting the medical treatment doses in order to investigate if the SeismoFit is able to detect changes in VO2max following medical treatment and physical rehabilitation in these patient groups.
The validity of SeismoFit will be based on difference and agreement between pre and post standard medical treatment compared with CPET. |
4-5 month | |
Secondary | Reliability of the SeimoFit VO2max estimation | A test day performed within 2-7 days after the follow-up test day in order to assess reliability of the SeismoFit estimation.
The reliability will be based on intra-method variation between the two test days. |
7 days |
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