Impedance cardiography (HYPERGRAPH) test to detect heart decompensation and replacement fibrosis in aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, single-center study will collect impedance cardiography (ICG) HYPERGRAPH data from six adult patients with moderate or severe aortic stenosis who have recent or planned cardiac MRI with late gadolinium enhancement and no history of myocardial infarction or cardiac amyloidosis. Participants will undergo upright and supine ICG testing and those results will be compared to CMR findings for replacement fibrosis. The aim is to determine whether ICG signatures of left ventricular decompensation correlate with CMR-detected replacement fibrosis. Data are intended to be preliminary and to inform the design of larger validation studies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Arthur P DeMarzo, MSc
• Email: ademarzo.dermed@att.net
• Phone: 1-630-668-4644

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.