Impedance Cardiography for Aortic Stenosis

Overseen By Arthur P DeMarzo, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dermed Diagnostics, Inc.

Disqualifiers: Myocardial infarction, Cardiac amyloidosis, Severe obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called impedance cardiography (ICG) to determine its effectiveness in detecting heart muscle issues in individuals with aortic stenosis, a condition where the heart's aortic valve narrows. Researchers aim to compare the results of this test with those from cardiac magnetic resonance (CMR), a specialized heart scan. They seek participants with aortic stenosis who have no history of heart attack or cardiac amyloidosis and have had or will have a CMR scan showing specific heart changes. Participants should have healthy skin at the test sites and be comfortable with the testing procedure. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance heart health diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that impedance cardiography is safe for detecting left ventricular decompensation in aortic stenosis patients?

Research shows that the test under study, called impedance cardiography (ICG), is usually easy for people to handle. One study found that ICG can assess heart function by measuring how electricity moves through the chest. Similar tests have reported no major side effects with ICG. Additionally, ICG has been used in other medical situations without significant safety issues. This suggests that the ICG test is likely safe for patients in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Impedance cardiography for aortic stenosis is unique because it offers a non-invasive way to assess heart function by measuring electrical impedance changes. Unlike traditional methods like echocardiography or cardiac catheterization, which can be invasive and resource-intensive, impedance cardiography provides real-time data on how well the heart compensates for stress. Researchers are excited about this technique because it could lead to earlier detection of heart failure decompensation, potentially improving patient outcomes with quicker and more targeted interventions.

What evidence suggests that impedance cardiography is effective for detecting left ventricular decompensation in aortic stenosis?

Research has shown that impedance cardiography (ICG) can help detect heart problems related to aortic stenosis. One study used ICG on patients in different positions (sitting up and lying down) and found it promising for identifying when the heart struggles to pump blood effectively. Another study discovered that ICG could track changes in heart function without invasive procedures. This trial will use the ICG upright/supine test to further explore its potential in detecting heart issues in patients with aortic stenosis. Overall, these studies support the idea that ICG can provide important information about heart health in aortic stenosis. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for patients with aortic stenosis who have had recent cardiac magnetic resonance (CMR) scans without a history of heart attack or cardiac amyloidosis. It's designed to test if an impedance cardiography (ICG) test can detect heart issues.

Inclusion Criteria

I have never had a heart attack or cardiac amyloidosis.

I have had or am scheduled for a heart scan with contrast.

I am 18 years old or older.

Exclusion Criteria

Prisoners

I have had a heart attack before.

I am younger than 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Impedance Cardiography Test

Participants undergo the ICG upright/supine test using the HYPERGRAPH to assess compensatory response and detect decompensation

1 day

1 visit (in-person)

Cardiac Magnetic Resonance Imaging

Participants undergo a CMR scan to measure replacement fibrosis and correlate with ICG test results

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ICG and CMR tests

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Impedance Cardiography Upright/Supine Test

Trial Overview The study tests the HYPERGRAPH, an ICG test, against CMR imaging to see if it can accurately identify left ventricular decompensation and replacement fibrosis in patients with aortic stenosis.

How Is the Trial Designed?

Group I: Impedance cardiography test Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Dermed Diagnostics, Inc.

Lead Sponsor

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07230964

Correlation Between an Impedance Cardiography Test for ... Gathering data on ICG readings in the upright and supine positions for detecting decompensation in patients with aortic stenosis is the ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/j.1520-037X.2007.05566.x

A New Approach for Low‐Cost Noninvasive Detection of ... Thirty-four outpatients undergoing echocardiographic testing were tested by ICG while sitting upright and supine. All patients had no symptoms ...

3. researchgate.net researchgate.net/publication/329092036_Impedance_cardiography_recent_applications_and_developments

Impedance cardiography: recent applications and ... A hybrid approach for quantifying aortic valve stenosis using impedance cardiography ... Changes in cardiac output and cerebral oxygenation during prone and ...

4. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2019.00184/full

Hemodynamic Response to the Head-Up Tilt Test in ... In the supine position we did not find any differences between patients with a positive and negative HUT test outcome (Figure 1A). Such result ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1936878X17307891

Role of Exercise Testing in Hypertrophic Cardiomyopathy Notably, gradients measured at peak exercise in the upright position and immediately following exercise (supine) show excellent correlation (36). Also, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07230964?aggFilters=status%3A%2CfunderType%3Aindustry

Correlation Between an Impedance Cardiography Test for ... The expected outcome of this study is a negative ICG test for decompensation in a moderate aortic stenosis patient with a CMR scan. Official ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9457179/

Exercise Testing in Aortic Stenosis: Safety, Tolerability ... - PMC Patients with positive stress test (67%) had a 7.6-fold increased risk of developing symptoms or sudden death at follow-up. Alborino et al., ...

8. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.116.025457

Stress Testing in Asymptomatic Aortic Stenosis | Circulation The present report provides a comprehensive review of the current available data on stress testing in aortic stenosis and subsequently ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0735109716010287

Natural History, Diagnostic Approaches, and Therapeutic ... Usefulness of the valvuloarterial impedance to predict adverse outcome in asymptomatic aortic stenosis. J Am Coll Cardiol, 54 (2009), pp. 1003-1011. View PDF ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9530126/

Improvement of hemodynamic parameters in aortic stenosis ... ICG uses the thoracic electrical impedance to assess hemodynamics and possesses good prospects in clinical application. A study showed that after coronary ...