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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Non-invasive hemodynamic measurements for pulmonary hypertension?

Research suggests that non-invasive methods like impedance cardiography can be useful for monitoring heart function in patients with pulmonary hypertension, providing valuable information during activities like exercise and potentially improving the prediction of patient outcomes. ^{1 2 3 4 5}

Is non-invasive cardiac monitoring safe for humans?

Non-invasive cardiac monitoring techniques, like pressure pulse waveform analysis and other less invasive methods, are generally considered safe and are used to assess heart function in various conditions, including pulmonary hypertension. ^{2 4 6 7 8}

How does non-invasive cardiac monitoring differ from other treatments for pulmonary hypertension?

This treatment is unique because it uses non-invasive methods like MRI and electrical impedance tomography (EIT) to monitor pulmonary artery pressure, unlike traditional methods that require invasive procedures. This approach allows for continuous monitoring without the need for specialized personnel, making it more accessible and less risky for patients. ^{2 9 10 11 12}

What is the purpose of this trial?

Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are severe clinical conditions that, despite advances in therapeutics over the past 20 years, lead to serious morbidity and mortality. Guidelines on the diagnosis and treatment of pulmonary hypertension (PH) recommend the use of a multiparametric risk stratification tool to determine severity of disease, which should guide initial therapy and therapy modulation. This multiparametric risk stratification schema includes objective assessment of exercise capacity, right ventricular function and hemodynamic parameters in order to classify patients into severity categories. Cardiac index (CI) and right atrial pressure (RAP), measured via right heart catheterization (RHC), are the hemodynamic parameters used in risk assessment of PH. Arguably, stroke volume index (SVI) is the most important hemodynamic parameter for assessment of PH severity and there is currently no validated method for noninvasive measurement of cardiac output (CO), CI or SVI. Currently, a major obstacle in the field is that hemodynamic measurements are not obtained on a regular basis in the risk assessment and therapy modulation of patients with PAH and CTEPH. If a noninvasive method of hemodynamic measurement could be correlated with other objective measurements of risk assessment, it could become an invaluable tool in therapy initiation and modulation in the ambulatory setting. This is a single center study to evaluate the use of non-invasive measurement of CO and stroke volume to assess risk and response to treatment in patients with PAH and non- operable CTEPH. We anticipate to enroll a total of 100 subjects at Ronald Reagan UCLA Medical Center. A maximum of 10 hour in total for the study including the consent process, pre-procedure care, RHC procedure, and follow up visit. The initial visit will be approximately 4 hours with the RHC procedure itself will only be 20 minutes. Each follow up visit will be 1.5 hour. Patients with known or suspected PAH or CTEPH will undergo a RHC as part of his or her standard of care. Three techniques of CO measurement will be performed sequentially at the time of the RHC. The device that will be used is the Edwards ClearSight system and EV1000 clinical platform, a device that measures NIBP. Patients will be followed over the period of 1 year every 3 months to obtain serial measurements for six-minute walk distance (6MWD), World Health Organization (WHO)/New York Heart Association Functional Class (FC), B-type natriuretic peptide (BNP) or N-terminal-pro hormone BNP (NT-proBNP), and non-invasive hemodynamic measurements. Additional visits will be scheduled to obtain the serial measurements one month prior and one month following if a patient is initiating or changing PH-specific therapy. As this is a study looking at the feasibility of non-invasive measurement of cardiac output and stroke volume for risk assessment and response to therapy in pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH), study personnel performing the study procedures will not be blinded to the clinical diagnosis and the management of the subject.

Research Team

Sonia Jasuja, M.D.

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Could Impedance Cardiography be a Non-Invasive Alternative Method of Measuring Cardiac Output in Patients with Pulmonary Hypertension? [2023]

2. England pubmed.ncbi.nlm.nih.gov

Hemodynamic monitoring in pulmonary arterial hypertension. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Signal-morphology impedance cardiography during incremental cardiopulmonary exercise testing in pulmonary arterial hypertension. [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

[Principles, usefulness, and limitations of recent circulatory monitoring]. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Value of impedance cardiography during 6-minute walk test in pulmonary hypertension. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Diagnostic Evaluation of Cardiovascular Physiology in Patients With Pulmonary Vascular Disease: Insights From the PVDOMICS Program. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Assessing hemodynamic response to submaximal exercise in pulmonary arterial hypertension patients using an implantable hemodynamic monitor. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Pulmonary hypertension: hemodynamic diagnosis and management. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A non-invasive assessment of cardiopulmonary hemodynamics with MRI in pulmonary hypertension. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Non-invasive monitoring of pulmonary artery pressure at the bedside. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Modern Invasive Hemodynamic Assessment of Pulmonary Hypertension. [2018]

12. England pubmed.ncbi.nlm.nih.gov

A new, simple, and accurate method for non-invasive estimation of pulmonary arterial pressure. [2019]