Recruiting

HYPERGRAPH

Sponsor:

Dermed Diagnostics, Inc.

Code:

NCT07230964

Conditions

Aortic Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Impedance Cardiography Upright/Supine Test

Study Details

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

Study ID

NCT07230964

Start date

Apr 30, 2026

Status verified date

Nov, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Oct 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • 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 Criteria:

  • • 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.

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Impedance Cardiography Upright/Supine Test

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.

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 and Locations

Central contacts

Arthur P DeMarzo, MSc

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

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Michael Markl, PhD

312-926-5268mmarkl@northwestern.edu

Emily Powell, CCRC

312-695-2956emily.powell@northwestern.edu

More Information

Sponsor

Dermed Diagnostics, Inc.

Last update posted

May 5, 2026

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dermed Diagnostics, Inc. on 2026-05-05.