Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05618093
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-05-11
First Post:
2022-11-08
Brief Title:
Non-Invasive Measurement of Cardiac Output and Stroke Volume in PAHCTEPH
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Use of Non-invasive Measurement of Cardiac Output and Stroke Volume to Assess Risk and Response to Treatment in Patients With PAH or CTEPH
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 15 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 WHONew 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
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 15 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 WHONew 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
Detailed Description:
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 patients with pulmonary arterial hypertension PAH and non- operable chronic thromboembolic pulmonary hypertension CTEPH We anticipate to enroll a total of 100 subjects at Ronald Reagan UCLA Medical Center
After informed consent is obtained the following procedure will be performed
Patients with known or suspected pulmonary arterial hypertension PAH or chronic thromboembolic pulmonary hypertension CTEPH will undergo a right heart catheterization RHC as part of his or her standard of care Three techniques of cardiac output CO measurement will be performed sequentially at the time of the RHC The order of cardiac output testing will be randomized after informed consent is obtained and prior to the procedure The operator performing the RHC procedure will be blinded to both the non-invasive blood pressure NIBP measurement and direct Fick cardiac output CO measurements while performing thermodilution cardiac output CO measurement
The device that will be used is the Edwards ClearSight system and EV1000 clinical platform a device that measures non-invasive blood pressure NIBP
Patients will be followed over the period of 1 year up to every 3 months to obtain serial measurements of six-minute walk distance 6MWD World Health Organization WHONew York Heart Association Functional Class FC and B-type natriuretic peptide BNP or N-terminal-pro hormone BNP NT-proBNP as part of standard of care These serial measurements will be collected from the patients medical record Non-invasive hemodynamic measurements will be performed for research purposes 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
After informed consent is obtained the following procedure will be performed
Patients with known or suspected pulmonary arterial hypertension PAH or chronic thromboembolic pulmonary hypertension CTEPH will undergo a right heart catheterization RHC as part of his or her standard of care Three techniques of cardiac output CO measurement will be performed sequentially at the time of the RHC The order of cardiac output testing will be randomized after informed consent is obtained and prior to the procedure The operator performing the RHC procedure will be blinded to both the non-invasive blood pressure NIBP measurement and direct Fick cardiac output CO measurements while performing thermodilution cardiac output CO measurement
The device that will be used is the Edwards ClearSight system and EV1000 clinical platform a device that measures non-invasive blood pressure NIBP
Patients will be followed over the period of 1 year up to every 3 months to obtain serial measurements of six-minute walk distance 6MWD World Health Organization WHONew York Heart Association Functional Class FC and B-type natriuretic peptide BNP or N-terminal-pro hormone BNP NT-proBNP as part of standard of care These serial measurements will be collected from the patients medical record Non-invasive hemodynamic measurements will be performed for research purposes 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None