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

NCT07230964 | Recruiting FDA Device

• 1 other identifier: ICG Decompensation LV Fibrosis
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Aortic Stenosis

Keywords

impedance cardiography; decompensation; aortic stenosis; fibrosis; myocardial replacement fibrosis

Outcome Measures

Primary Outcomes (1)

• Correlation between ICG decompensation detection and replacement fibrosis measured by 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.

  The assessment for each participant will be performed immediately following the one-time ICG test and CMR scan.

Study Arms (1)

Impedance cardiography test

EXPERIMENTAL

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.

Device: Impedance Cardiography Upright/Supine Test

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.

Impedance cardiography test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dermed Diagnostics, Inc.: lead
• Northwestern University: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

• DeMarzo AP. Using impedance cardiography with postural change to stratify patients with hypertension. Ther Adv Cardiovasc Dis. 2011 Jun;5(3):139-48. doi: 10.1177/1753944711406770. Epub 2011 Apr 28.

  PMID: 21527444 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Fibrosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arthur P DeMarzo, MSc

CONTACT

1-630-668-4644; ademarzo.dermed@att.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2025
• First Posted: November 17, 2025
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)