Non-Invasive Cardiac Monitoring for Pulmonary Hypertension

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Atrial fibrillation, Valve issues, Renal disease, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method for measuring heart function without invasive procedures for individuals with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). These conditions cause high blood pressure in the lungs and can lead to heart issues. The goal is to determine if non-invasive hemodynamic measurements can assist doctors in deciding on treatments and monitoring progress more easily. The trial seeks participants diagnosed with PAH or CTEPH who are scheduled for a right heart catheterization, a test to check heart and lung pressure. As an unphased trial, this study offers participants the chance to contribute to innovative research that could simplify heart monitoring and treatment decisions.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatments, as the study focuses on non-invasive monitoring rather than medication changes.

What prior data suggests that this non-invasive cardiac monitoring method is safe for patients with pulmonary hypertension?

Research has shown that non-invasive methods to measure blood flow, like those used in this study, are generally easy for patients to handle. One study found that these methods can safely predict how blood moves in the lungs using simple measurements. This allows doctors to obtain important heart and lung information without surgery.

These non-invasive techniques are often used alongside standard tests like CT scans and MRIs. Research indicates they provide reliable information without causing major side effects. Since these methods don't involve surgery or entering the body, they are usually considered safe and rarely lead to problems.

Overall, using non-invasive methods in medical settings is widely accepted as safe, making them a comfortable choice for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about non-invasive hemodynamic measurements for pulmonary hypertension because they offer a new way to monitor heart health without the need for invasive procedures. Currently, managing conditions like pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) often involves right heart catheterization, which is more invasive. This new method allows for continuous monitoring of heart function using external sensors, making it safer and more comfortable for patients. By providing real-time data, it could lead to more personalized and timely adjustments in treatment, potentially improving outcomes for those affected by these conditions.

What evidence suggests that this non-invasive cardiac monitoring is effective for pulmonary hypertension?

Research has shown that non-invasive methods effectively measure heart function by assessing cardiac output and stroke volume, which are vital for understanding heart health in conditions like pulmonary hypertension (PH). In this trial, participants with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) will undergo non-invasive hemodynamic measurements. Studies have found that these techniques can predict blood flow through the lungs, crucial for understanding the severity of PAH and CTEPH. Accurate, non-invasive measurements help doctors monitor and adjust treatments more easily for these conditions. Overall, these methods provide valuable insights without requiring more invasive procedures. ^{1 2 3 6 7}

Who Is on the Research Team?

Sonia Jasuja, M.D.

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed or suspected pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). They must be undergoing a right heart catheterization as standard care and able to consent. It's not suitable for those with extreme body weights, certain heart valve issues, atrial fibrillation, or end-stage renal disease.

Inclusion Criteria

The patient must understand and sign informed consent form (ICF).

I have or might have high blood pressure in the lungs before starting or changing treatment.

I am a patient with PAH or CTEPH and will have a heart catheter test.

Exclusion Criteria

My BMI is either below 20 or above 35.

I am shorter than 120 cm.

I have been diagnosed with atrial fibrillation, valve issues, or severe kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Visit and Right Heart Catheterization

Initial visit includes consent process, pre-procedure care, and right heart catheterization (RHC) with non-invasive cardiac output measurements

1 day

1 visit (in-person, approximately 4 hours)

Follow-up

Participants are monitored every 3 months for 1 year to obtain serial measurements of six-minute walk distance, WHO/NYHA Functional Class, BNP/NT-proBNP, and non-invasive hemodynamic measurements

12 months

4 visits (in-person, every 3 months)

Additional Monitoring

Additional visits scheduled one month prior and one month following initiation or change in PH-specific therapy to obtain serial measurements

As needed

What Are the Treatments Tested in This Trial?

Interventions

• Non-invasive hemodynamic measurements

Trial Overview The study tests non-invasive methods to measure cardiac output and stroke volume in PAH/CTEPH patients at UCLA Medical Center. It aims to see if these measurements can help assess risk and monitor treatment response without invasive procedures. Participants will have follow-ups every three months for one year.

How Is the Trial Designed?

Group I: Patients diagnosed with PAH or CTEPH Experimental Treatment 1 Intervention

Patients with a confirmed diagnosis or suspected diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) prior to initiation or change in therapy.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

A definitive diagnosis of pulmonary hypertension requires invasive measurement of mean pulmonary artery pressure, specifically a value of 25 mm Hg or higher during right heart catheterization, which is crucial for accurate classification and treatment.

Multi-point pressure/flow measurements can enhance the understanding of pulmonary vascular resistance, aiding in early disease identification and treatment response assessment, while also helping to differentiate between types of pulmonary vasculopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern Invasive Hemodynamic Assessment of Pulmonary Hypertension. Pagnamenta, A., Lador, F., Azzola, A., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05618093

Non-Invasive Measurement of Cardiac Output and Stroke ... This is a single center study to evaluate the use of non-invasive measurement of cardiac output and stroke volume to assess risk and response to treatment in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8528681/

Noninvasive prediction of pulmonary hemodynamics in ... Easily measurable parameters from chest CT examinations enable prediction of pulmonary hemodynamics. ECG-gated CTPA is superior to non-gated CT.

3. jhltonline.org jhltonline.org/article/S1053-2498(25)01858-3/fulltext

Hemodynamic, echocardiographic, and demographic ... The database contains demographic data, hemodynamic evaluations, and non-invasive test results of patients with pulmonary arterial ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11900574/

A Non-Invasive Approach to Pulmonary Hypertension - PMC This review aims to provide an in-depth summary of the current data on advanced non-invasive imaging techniques for PH.

5. thrombosisresearch.com thrombosisresearch.com/article/S0049-3848(11)00116-2/fulltext

A simple non-invasive diagnostic algorithm for ruling out ... Our aim was to construct a diagnostic model for ruling out chronic thromboembolic pulmonary hypertension (CTEPH) in symptomatic patients after acute pulmonary ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666572724000361

Revisiting hemodynamic definition: Incidence of chronic ... According to the new updated criteria for PH, 36% of intermediate-high- and high-risk PE patients met the criteria of CTEPH at 3 months of follow-up.

7. dirjournal.org dirjournal.org/articles/imaging-in-chronic-thromboembolic-pulmonary-hypertension-review-of-the-current-literature/dir.2025.253249

Imaging in chronic thromboembolic pulmonary hypertension These MRI-derived parameters have particular importance in CTEPH because they correlate strongly with invasive hemodynamic measurements.