Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07230964

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

Led by Dermed Diagnostics, Inc. · Updated on 2026-05-05

6

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

D

Dermed Diagnostics, Inc.

Lead Sponsor

N

Northwestern University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 such a scan
  • History of moderate aortic stenosis without replacement fibrosis, or moderate aortic stenosis with symptoms and replacement fibrosis, or severe aortic stenosis with replacement fibrosis before aortic valve replacement
  • Able to understand and provide informed consent in English
  • Intact, healthy skin at electrode application sites
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant or breastfeeding women
  • Unable to provide consent
  • Prisoners
  • History of myocardial infarction
  • History of cardiac amyloidosis
  • Presence of metal implants such as IUD, braces, eye implants, pacemakers, defibrillators, or other electronic cardiac implants
  • Claustrophobia or fear of small spaces
  • Severe obesity (BMI over 40) preventing accurate ICG measurement
  • Active skin conditions like rashes, open wounds, or significant sensitivity at electrode sites

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

A

Arthur P DeMarzo, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

SCREENING

Number of Arms

1

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