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Impedance Cardiography for Aortic Stenosis and Heart Damage

This study is looking at how well a test called Impedance Cardiography (ICG), specifically the HYPERGRAPH test, can find early signs of heart weakening (left ventricular decompensation) in people with aortic stenosis. Aortic stenosis is a condition where the heart's aortic valve narrows. The researchers want to see if the ICG test results match up with heart damage (replacement fibrosis) seen on a special MRI scan called a Cardiac Magnetic Resonance (CMR) scan. They are enrolling 6 adults, aged 18 or older, who have aortic stenosis and have recently had or are scheduled for a CMR scan. You cannot have a history of heart attack or cardiac amyloidosis. The study aims to find a way to detect heart damage earlier, before it becomes severe. The current status of this study is unclear.

Study design
This is an interventional study enrolling 6 participants. It aims to compare the ICG test results with findings from a CMR scan.
What's involved
You will undergo a one-time Impedance Cardiography Upright/Supine Test. This will be performed immediately after or in conjunction with a CMR scan.
Compensation
Not stated in the trial record.
Follow-up
The assessment for each participant will be performed immediately following the one-time ICG test and CMR scan, so there is no long-term follow-up described.

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NCT07230964

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

Recruiting
NAAges 18+InterventionalScreening
Dermed Diagnostics, Inc.
~6 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Impedance Cardiography Upright/Supine Test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation between ICG decompensation detection and replacement fibrosis measured by CMR scan
Measured over The assessment for each participant will be performed immediately following the one-time ICG test and CMR scan.

Conditions

Aortic Stenosis

Explore related trials

Aortic Valve StenosisCardiac Fibrosis

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Arthur P DeMarzo, MSc
[email protected]
1-630-668-4644
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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

• 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.

What this trial measures

  • Correlation between ICG decompensation detection and replacement fibrosis measured by CMR scanThe assessment for each participant will be performed immediately following the one-time ICG test and CMR scan.

    Look for a negative ICG test for decompensation correlating with a CMR scan indicating a very low extracellular volume and a positive ICG test for decompensation correlating with a CMR scan indicating a very high extracellular volume.