Impedance cardiography (HYPERGRAPH) test to detect heart decompensation and replacement fibrosis in aortic stenosis
Early Feasibility Study of the Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis
This project will test whether a quick impedance cardiography (HYPERGRAPH) test can detect left ventricular decompensation linked to replacement fibrosis in people with aortic stenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dermed Diagnostics, Inc. Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07230964 on ClinicalTrials.gov |
What this trial studies
This observational, single-center study will collect impedance cardiography (ICG) HYPERGRAPH data from six adult patients with moderate or severe aortic stenosis who have recent or planned cardiac MRI with late gadolinium enhancement and no history of myocardial infarction or cardiac amyloidosis. Participants will undergo upright and supine ICG testing and those results will be compared to CMR findings for replacement fibrosis. The aim is to determine whether ICG signatures of left ventricular decompensation correlate with CMR-detected replacement fibrosis. Data are intended to be preliminary and to inform the design of larger validation studies.
Who should consider this trial
Good fit: Adults (≥18) with moderate or severe aortic stenosis who have a recent or scheduled CMR with late gadolinium enhancement, no prior myocardial infarction or cardiac amyloidosis, and intact skin at electrode sites are the ideal candidates.
Not a fit: Patients with prior myocardial infarction or cardiac amyloidosis, those with implanted devices or metal implants that interfere with ICG, pregnant or breastfeeding women, prisoners, or people without a qualifying CMR are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the HYPERGRAPH ICG test could offer a quick, noninvasive way to identify patients at risk for irreversible heart damage so clinicians can consider earlier intervention.
How similar studies have performed: Cardiac MRI with late gadolinium enhancement is an established method for detecting replacement fibrosis, whereas using impedance cardiography (HYPERGRAPH) to detect fibrosis-associated decompensation is a novel approach that is not yet validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Male or female at least 18 years of age. * No prior history of myocardial infarction or cardiac amyloidosis. * Recent CMR scan with late gadolinium enhancement or scheduled for CMR scan with late gadolinium enhancement. * A history of: * Moderate aortic stenosis and no replacement fibrosis OR Moderate aortic stenosis and symptoms who has replacement fibrosis OR Severe aortic stenosis with replacement fibrosis prior to aortic valve replacement. * Able to comprehend and provide informed consent in English. * Participants must have intact, healthy skin at the electrode application sites. Exclusion Criteria: * • Under 18 years of age * Pregnant or breastfeeding women * Unable to consent * Prisoners * History of myocardial infarction * History of cardiac amyloidosis * Patients with any metal or implant such as IUD, braces, metal fragments implants in the eye, pacemakers (especially Minute Ventilation pacemakers with the MV function activated) defibrillators, or any other electronic cardiac implant. * Claustrophobic or afraid or small places. * Severe obesity (BMI \> 40) that impairs accurate ICG measurement due to difficulties in electrode placement or excessive impedance. * Active skin conditions, such as rashes, open wound or significant skin sensitivity at the electrode placement sites.
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Arthur P DeMarzo, MSc
- Email: ademarzo.dermed@att.net
- Phone: 1-630-668-4644
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.