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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Dermed Diagnostics, Inc.
Study ID
NCT07230964
Status
Recruiting

Conditions

  • Aortic Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Impedance Cardiography Upright/Supine Test — DEVICE
    This ICG upright/supine test is a comparison of \[dZ/dt\]max in the supine position to \[dZ/dt\]max in an upright position for assessing decompensation.

Study Details

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 Dates

Start date
Apr 30, 2026
Status verified
Nov 2025
Primary completion
Oct 23, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SCREENING

Arms

  • Experimental: Impedance cardiography test
    The ICG upright/supine test, using the HYPERGRAPH, will be used to show the difference in the compensatory response between normal LV function and decompensation in HF.

Primary Outcome Measure

Correlation between ICG decompensation detection and replacement fibrosis measured by CMR scan [ Time Frame: The assessment for each participant will be performed immediately following the one-time ICG test and CMR scan. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Michael Markl, PhD
312-926-5268
Emily Powell, CCRC
312-695-2956
Corin Cameron (SUB_INVESTIGATOR)

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