Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis

In brief

The purpose of this study is to evaluate the effectiveness of impedance cardiography (ICG), the HYPERGRAPH test, in detecting left ventricular decompensation in patients with aortic stenosis, compared to cardiac magnetic resonance (CMR) imaging findings. The study aims to obtain usable ICG test data on six patients with aortic stenosis who have recently undergone CMR scans with late gadolinium enhancement, and who do not have a history of myocardial infarction or cardiac amyloidosis. The hypothesis to be tested is that the HYPERGRAPH can accurately detect left ventricular decompensation associated with replacement fibrosis obtained from CMR imaging.

Key facts

Study ID

NCT07230964

Run by

Dermed Diagnostics, Inc.

People needed

6

Starts

2026-04-30

Expected to finish

2026-11-30

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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 it is running

• Northwestern University — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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