Evaluating a new method for estimating fitness in heart failure and ischemic heart disease patients
Validity of SeismoFit VO2max Estimation in Patients With Heart Failure or Ischemic Heart Disease
This study is testing a new device called SeismoFit to see if it can accurately measure fitness levels in people with heart failure and ischemic heart disease without needing them to exercise.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Gentofte) |
| Trial ID | NCT05520307 on ClinicalTrials.gov |
What this trial studies
This study investigates the validity and reliability of the SeismoFit device for estimating VO2max in patients with heart failure (HF) and ischemic heart disease (IHD). It consists of three parts: a cross-sectional analysis involving 140 patients, a longitudinal follow-up with 100 patients, and a test-retest evaluation with 40 patients. The SeismoFit device uses seismocardiography to measure cardiac performance non-invasively at rest, providing a potential alternative to traditional exercise testing methods. The study aims to assess the effectiveness of this non-exercise VO2max prediction model in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include patients with heart failure or ischemic heart disease who are approved for exercise testing by a cardiologist.
Not a fit: Patients with absolute contraindications to training or conditions preventing maximal exercise testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and cost-effective method for assessing cardiorespiratory fitness in patients with heart conditions.
How similar studies have performed: While the use of seismocardiography for VO2max estimation is a novel approach, similar studies have shown promise in non-invasive cardiac assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gentofte
- Herlev and Gentofte Hospital — Gentofte, Denmark (Recruiting)
Study contacts
- Principal investigator: Jørn W Helge, Professor — Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen
- Study coordinator: Jørn W Helge, Professor
- Email: jhelge@sund.ku.dk
- Phone: +45 28757506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.