NCT07230964 · Dermed Diagnostics, Inc.
Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Chicago, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations