Patients diagnosed with PAH or CTEPH for Pulmonary arterial hypertension

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pulmonary arterial hypertension+6 More
Non-invasive hemodynamic measurements - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions
  • Pulmonary arterial hypertension
  • Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
  • Pulmonary Arterial Hypertension

Treatment Effectiveness

Study Objectives

7 Primary · 3 Secondary · Reporting Duration: 12 months

12 months
Nesiritide
World Health Organization (WHO)/New York Heart Association Functional Class (FC)
Bronchial Provocation Tests
cardiac index (CI)
Cardiac Output
Heart rate
six-minute walk distance (6MWD)
stroke volume (SV)
stroke volume index (SVI)
Pulmonary Vascular Resistance

Trial Safety

Trial Design

1 Treatment Group

Patients diagnosed with PAH or CTEPH
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Patients diagnosed with PAH or CTEPH · No Placebo Group · N/A

Patients diagnosed with PAH or CTEPH
Device
Experimental Group · 1 Intervention: Non-invasive hemodynamic measurements · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Non-invasive hemodynamic measurements
2018
N/A
~120

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,405 Previous Clinical Trials
6,941,199 Total Patients Enrolled
Sonia Jasuja, M.D.Principal InvestigatorUniversity of California, Los Angeles

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are undergoing RHC as part of your standard of care.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References