Pulmonary Arterial HypertensionNCT05618093
Non-Invasive Measurement of Cardiac Output and Stroke Volume in PAH/CTEPH
A study testing Non-invasive hemodynamic measurements in people with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Non-invasive hemodynamic measurements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2023to 26 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years of age.
- The patient must understand and sign informed consent form (ICF).
- 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.
- PAH or CTEPH patients undergoing right heart catheterization (RHC) as part of their standard of care.
Who cannot join
- BMI < 20 or BMI > 35.
- Height less than 120 cm.
- Diagnosis of atrial fibrillation, aortic or mitral valve insufficiency or stenosis, or end-stage renal disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
About this study
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
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.
Read more
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.
Read the 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 (WHO)/New 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 patient's 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.
- Being tested
- Non-invasive hemodynamic measurements
- Keywords
- Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, PAH, CTEPH, Non-invasive Hemodynamics, Non-invasive Blood Pressure
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive hemodynamic measurementsDevice
Also called Non-invasive blood pressure (NIBP)
A patient profile will be set up in the Edwards EV1000 clinical platform by inputting the patient's demographic information. One or two Edwards ClearSight finger cuffs will be placed on the index, middle, and/or ring finger on one hand of the patient. A pressure controller will be secured by a forearm strap where the finger cuffs will be connected to the pressure controller. The pressure controller will be connected to the Edwards EV1000 clinical platform monitor. A heart reference sensor (HRS) will be connected to the pressure controller, a finger cuff, and to the patient at heart level. The Edwards EV1000 clinical platform will calibrate the finger probes, then record measurements for 10-30 seconds. If two finger probes are available, measurements will alternate between fingers.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with PAH or CTEPH | Experimental | 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. Receives: Device: Non-invasive hemodynamic measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume (SV)
Stroke Volume (SV) is the volume of blood in millilitres ejected from the each ventricle due to the contraction of the heart muscle which compresses these ventricles.
Measured: 12 months
stroke volume index (SVI)
Stroke Volume Index (SVI) relates SV to body surface area (BSA), thus relating heart performance to the size of the individual. The unit of measurement is millilitres per square metre (ml/m2).
Measured: 12 months
cardiac output (CO)
Cardiac Output (CO) is the amount of blood the heart pumps from each ventricle per minute. It is usually expressed in litres per minute (L/min).
Measured: 12 months
cardiac index (CI)
Cardiac index (CI) is the cardiac output proportional to the body surface area (BSA). The unit of measurement is litres per minute per square metre (L/min/m2).
Measured: 12 months
systemic vascular resistance (SVR)
Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.
The units for SVR are most commonly expressed as pressure (mmHg) divided by cardiac output (mL/min), or mmHg⋅min⋅mL^-1
Measured: 12 months
blood pressure (BP)
The pressure of the blood in the circulatory system, often measured for diagnosis since it is closely related to the force and rate of the heartbeat and the diameter and elasticity of the arterial walls.
Systolic Blood Pressure in mmHg Diastolic Blood Pressure in mmHg
Measured: 12 months
heart rate (HR)
The number of heartbeats per unit of time, usually per minute.
Measured in beats per minute (BPM)
Measured: 12 months
Secondary outcomes (3)
six-minute walk distance (6MWD)
The distance covered over a time of 6 minutes. This is used as the outcome by which to compare changes in performance capacity.
Measured: 12 months
B-type natriuretic peptide (BNP) or N-terminal-pro hormone BNP (NT-proBNP)
B-type natriuretic peptide (BNP) is a hormone produced by your heart. N-terminal (NT)-pro hormone BNP (NT-proBNP) is a non-active prohormone that is released from the same molecule that produces BNP. Both BNP and NT-proBNP are released in response to changes in pressure inside the heart. These changes can be related to heart failure and other cardiac problems. Levels goes up when heart failure develops or gets worse, and levels goes down when heart failure is stable.
Measured: 12 months
World Health Organization (WHO)/New York Heart Association Functional Class (FC)
The World Health Organization functional classification (WHO-FC) is a tool used to measure disease severity in patients with PAH whereby health care providers (HCPs) use patient reports of symptom experience and activity limitations to make their assessment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start2 Mar 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Why it stopped: Study device no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Jasuja, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618093
- Sponsor's protocol ID
- 20-001981
- Status last verified
- Jan 2026
- First submitted
- 8 Nov 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Galie N, Channick RN, Frantz RP, Grunig E, Jing ZC, Moiseeva O, Preston IR, Pulido T, Safdar Z, Tamura Y, McLaughlin VV. Risk stratification and medical therapy of pulmonary arterial hypertension. Eur Respir J. 2019 Jan 24;53(1):1801889. doi: 10.1183/13993003.01889-2018. Print 2019 Jan.
PubMed 30545971Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
PubMed 26320113Raina A, Humbert M. Risk assessment in pulmonary arterial hypertension. Eur Respir Rev. 2016 Dec;25(142):390-398. doi: 10.1183/16000617.0077-2016.
PubMed 27903661Maron BA. Hemodynamics should be the primary approach to diagnosing, following, and managing pulmonary arterial hypertension. Can J Cardiol. 2015 Apr;31(4):515-20. doi: 10.1016/j.cjca.2014.09.021. Epub 2014 Sep 28.
PubMed 25742869D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. doi: 10.7326/0003-4819-115-5-343.
PubMed 1863023Sandoval J, Bauerle O, Palomar A, Gomez A, Martinez-Guerra ML, Beltran M, Guerrero ML. Survival in primary pulmonary hypertension. Validation of a prognostic equation. Circulation. 1994 Apr;89(4):1733-44. doi: 10.1161/01.cir.89.4.1733.
PubMed 8149539Weatherald J, Boucly A, Chemla D, Savale L, Peng M, Jevnikar M, Jais X, Taniguchi Y, O'Connell C, Parent F, Sattler C, Herve P, Simonneau G, Montani D, Humbert M, Adir Y, Sitbon O. Prognostic Value of Follow-Up Hemodynamic Variables After Initial Management in Pulmonary Arterial Hypertension. Circulation. 2018 Feb 13;137(7):693-704. doi: 10.1161/CIRCULATIONAHA.117.029254. Epub 2017 Oct 25.
PubMed 29070502Weatherald J, Boucly A, Launay D, Cottin V, Prevot G, Bourlier D, Dauphin C, Chaouat A, Savale L, Jais X, Jevnikar M, Traclet J, De Groote P, Simonneau G, Hachulla E, Mouthon L, Montani D, Humbert M, Sitbon O. Haemodynamics and serial risk assessment in systemic sclerosis associated pulmonary arterial hypertension. Eur Respir J. 2018 Oct 18;52(4):1800678. doi: 10.1183/13993003.00678-2018. Print 2018 Oct.
PubMed 30209196Yung GL, Fedullo PF, Kinninger K, Johnson W, Channick RN. Comparison of impedance cardiography to direct Fick and thermodilution cardiac output determination in pulmonary arterial hypertension. Congest Heart Fail. 2004 Mar-Apr;10(2 Suppl 2):7-10. doi: 10.1111/j.1527-5299.2004.03406.x.
PubMed 15073478Dupuis M, Noel-Savina E, Prevot G, Tetu L, Pillard F, Riviere D, Didier A. Determination of Cardiac Output in Pulmonary Hypertension Using Impedance Cardiography. Respiration. 2018;96(6):500-506. doi: 10.1159/000486423. Epub 2018 Feb 9.
PubMed 29428946Humbert M, Guignabert C, Bonnet S, Dorfmuller P, Klinger JR, Nicolls MR, Olschewski AJ, Pullamsetti SS, Schermuly RT, Stenmark KR, Rabinovitch M. Pathology and pathobiology of pulmonary hypertension: state of the art and research perspectives. Eur Respir J. 2019 Jan 24;53(1):1801887. doi: 10.1183/13993003.01887-2018. Print 2019 Jan.
PubMed 30545970Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
PubMed 30545968Humbert M, Sitbon O, Yaici A, Montani D, O'Callaghan DS, Jais X, Parent F, Savale L, Natali D, Gunther S, Chaouat A, Chabot F, Cordier JF, Habib G, Gressin V, Jing ZC, Souza R, Simonneau G; French Pulmonary Arterial Hypertension Network. Survival in incident and prevalent cohorts of patients with pulmonary arterial hypertension. Eur Respir J. 2010 Sep;36(3):549-55. doi: 10.1183/09031936.00057010. Epub 2010 Jun 18.
PubMed 20562126Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaici A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Cottin V, Degano B, Jais X, Montani D, Souza R, Simonneau G. Survival in patients with idiopathic, familial, and anorexigen-associated pulmonary arterial hypertension in the modern management era. Circulation. 2010 Jul 13;122(2):156-63. doi: 10.1161/CIRCULATIONAHA.109.911818. Epub 2010 Jun 28.
PubMed 20585011Boucly A, Weatherald J, Savale L, Jais X, Cottin V, Prevot G, Picard F, de Groote P, Jevnikar M, Bergot E, Chaouat A, Chabanne C, Bourdin A, Parent F, Montani D, Simonneau G, Humbert M, Sitbon O. Risk assessment, prognosis and guideline implementation in pulmonary arterial hypertension. Eur Respir J. 2017 Aug 3;50(2):1700889. doi: 10.1183/13993003.00889-2017. Print 2017 Aug.
PubMed 28775050
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05618093
- Acronym / sponsor ID
- 20-001981
- Keywords
- Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, PAH, CTEPH, Non-invasive Hemodynamics, Non-invasive Blood Pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study device no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (WHO)/New 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 patient's 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with PAH or CTEPH | Experimental | Device: Non-invasive hemodynamic measurementsPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient ≥ 18 years of age.
- The patient must understand and sign informed consent form (ICF).
- 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.
- PAH or CTEPH patients undergoing right heart catheterization (RHC) as part of their standard of care.
Key exclusion criteria (3 listed)
- BMI < 20 or BMI > 35.
- Height less than 120 cm.
- Diagnosis of atrial fibrillation, aortic or mitral valve insufficiency or stenosis, or end-stage renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive hemodynamic measurementsAlso: Non-invasive blood pressure (NIBP)A patient profile will be set up in the Edwards EV1000 clinical platform by inputting the patient's demographic information. One or two Edwards ClearSight finger cuffs will be placed on the index, middle, and/or ring finger on one hand of the patient. A pressure controller will be secured by a forearm strap where the finger cuffs will be connected to the pressure controller. The pressure controller will be connected to the Edwards EV1000 clinical platform monitor. A heart reference sensor (HRS) will be connected to the pressure controller, a finger cuff, and to the patient at heart level. The Edwards EV1000 clinical platform will calibrate the finger probes, then record measurements for 10-30 seconds. If two finger probes are available, measurements will alternate between fingers. | Device | Patients diagnosed with PAH or CTEPH |
Primary outcome
stroke volume (SV)
Time frame: 12 months
Stroke Volume (SV) is the volume of blood in millilitres ejected from the each ventricle due to the contraction of the heart muscle which compresses these ventricles.
stroke volume index (SVI)
Time frame: 12 months
Stroke Volume Index (SVI) relates SV to body surface area (BSA), thus relating heart performance to the size of the individual. The unit of measurement is millilitres per square metre (ml/m2).
cardiac output (CO)
Time frame: 12 months
Cardiac Output (CO) is the amount of blood the heart pumps from each ventricle per minute. It is usually expressed in litres per minute (L/min).
cardiac index (CI)
Time frame: 12 months
Cardiac index (CI) is the cardiac output proportional to the body surface area (BSA). The unit of measurement is litres per minute per square metre (L/min/m2).
systemic vascular resistance (SVR)
Time frame: 12 months
Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature. The units for SVR are most commonly expressed as pressure (mmHg) divided by cardiac output (mL/min), or mmHg⋅min⋅mL^-1
blood pressure (BP)
Time frame: 12 months
The pressure of the blood in the circulatory system, often measured for diagnosis since it is closely related to the force and rate of the heartbeat and the diameter and elasticity of the arterial walls. Systolic Blood Pressure in mmHg Diastolic Blood Pressure in mmHg
heart rate (HR)
Time frame: 12 months
The number of heartbeats per unit of time, usually per minute. Measured in beats per minute (BPM)
3 secondary outcomes
six-minute walk distance (6MWD)
Time frame: 12 months
B-type natriuretic peptide (BNP) or N-terminal-pro hormone BNP (NT-proBNP)
Time frame: 12 months
World Health Organization (WHO)/New York Heart Association Functional Class (FC)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 30545971Galie N, Channick RN, Frantz RP, Grunig E, Jing ZC, Moiseeva O, Preston IR, Pulido T, Safdar Z, Tamura Y, McLaughlin VV. Risk stratification and medical therapy of pulmonary arterial hypertension. Eur Respir J. 2019 Jan 24;53(1):1801889. doi: 10.1183/13993003.01889-2018. Print 2019 Jan.
- Results publication: PubMed 26320113Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
- Results publication: PubMed 27903661Raina A, Humbert M. Risk assessment in pulmonary arterial hypertension. Eur Respir Rev. 2016 Dec;25(142):390-398. doi: 10.1183/16000617.0077-2016.
- Results publication: PubMed 25742869Maron BA. Hemodynamics should be the primary approach to diagnosing, following, and managing pulmonary arterial hypertension. Can J Cardiol. 2015 Apr;31(4):515-20. doi: 10.1016/j.cjca.2014.09.021. Epub 2014 Sep 28.
- Results publication: PubMed 1863023D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. doi: 10.7326/0003-4819-115-5-343.
- Results publication: PubMed 8149539Sandoval J, Bauerle O, Palomar A, Gomez A, Martinez-Guerra ML, Beltran M, Guerrero ML. Survival in primary pulmonary hypertension. Validation of a prognostic equation. Circulation. 1994 Apr;89(4):1733-44. doi: 10.1161/01.cir.89.4.1733.
- Results publication: PubMed 29070502Weatherald J, Boucly A, Chemla D, Savale L, Peng M, Jevnikar M, Jais X, Taniguchi Y, O'Connell C, Parent F, Sattler C, Herve P, Simonneau G, Montani D, Humbert M, Adir Y, Sitbon O. Prognostic Value of Follow-Up Hemodynamic Variables After Initial Management in Pulmonary Arterial Hypertension. Circulation. 2018 Feb 13;137(7):693-704. doi: 10.1161/CIRCULATIONAHA.117.029254. Epub 2017 Oct 25.
- Results publication: PubMed 30209196Weatherald J, Boucly A, Launay D, Cottin V, Prevot G, Bourlier D, Dauphin C, Chaouat A, Savale L, Jais X, Jevnikar M, Traclet J, De Groote P, Simonneau G, Hachulla E, Mouthon L, Montani D, Humbert M, Sitbon O. Haemodynamics and serial risk assessment in systemic sclerosis associated pulmonary arterial hypertension. Eur Respir J. 2018 Oct 18;52(4):1800678. doi: 10.1183/13993003.00678-2018. Print 2018 Oct.
- Results publication: PubMed 15073478Yung GL, Fedullo PF, Kinninger K, Johnson W, Channick RN. Comparison of impedance cardiography to direct Fick and thermodilution cardiac output determination in pulmonary arterial hypertension. Congest Heart Fail. 2004 Mar-Apr;10(2 Suppl 2):7-10. doi: 10.1111/j.1527-5299.2004.03406.x.
- Results publication: PubMed 29428946Dupuis M, Noel-Savina E, Prevot G, Tetu L, Pillard F, Riviere D, Didier A. Determination of Cardiac Output in Pulmonary Hypertension Using Impedance Cardiography. Respiration. 2018;96(6):500-506. doi: 10.1159/000486423. Epub 2018 Feb 9.
- Results publication: PubMed 30545970Humbert M, Guignabert C, Bonnet S, Dorfmuller P, Klinger JR, Nicolls MR, Olschewski AJ, Pullamsetti SS, Schermuly RT, Stenmark KR, Rabinovitch M. Pathology and pathobiology of pulmonary hypertension: state of the art and research perspectives. Eur Respir J. 2019 Jan 24;53(1):1801887. doi: 10.1183/13993003.01887-2018. Print 2019 Jan.
- Results publication: PubMed 30545968Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Jasuja, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive hemodynamic measurements in people with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke volume (SV) (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05618093, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.