Chronic Thromboembolic Pulmonary HypertensionNCT05843500
Chronic Thromboembolic Disease Registry
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Chronic Thromboembolic Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this patient registry is to learn about the natural history in patients with chronic thromboembolic disease (CTD) and/or chronic thromboembolic pulmonary hypertension (CTEPH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, Chronic Thromboembolic Disease
- What is being tested?
- Survey
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Jul 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with diagnosed chronic thromboembolic disease (CTED) or chronic thromboembolic pulmonary hypertension (CTEPH)
Who may be able to join
- Patients referred with CTED and/or CTEPH defined as:
- Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest with pulmonary vascular resistance (PVR) > 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2 WU at rest, have exercise limitations from chronic thromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH)
- Radiologic finding of chronic thromboembolic disease, including abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram
- Post-embolic exercise intolerance and evidence of chronic thromboembolic disease in the absence of resting pulmonary hypertension
- Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
- Age ≥ 18 years
Who cannot join
- Main cause of PH other than World Health Organization (WHO) group 4 (CTEPH)
- Patient's refusal to participate in clinical research and/or receive intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Miles Conrad, MD, 415-353-1300, miles.conrad@ucsf.edu
Xiao Wu, MD, 628-286-7340, xiao.wu@ucsf.edu
About this study
Official title: Chronic Thromboembolic Disease: A Prospective Registry
The goal of this patient registry is to learn about the natural history in patients with chronic thromboembolic disease (CTD) and/or chronic thromboembolic pulmonary hypertension (CTEPH). The main question[s] it aims to answer are:
- Long-term outcome after various types of treatment, including medication, balloon pulmonary angioplasty, and pulmonary endarterectomy
- Effect of treatment on patient's quality of life and exercise tolerance Participants will be followed longitudinally to assess their health outcomes and quality of life via chart review and health quality surveys.
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Patients who received medical, surgical or interventional treatment for chronic thromboembolic pulmonary hypertension will be followed and given quality of life questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Chronic thromboembolic disease | Patients with chronic thromboembolic disease/pulmonary hypertension Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of patients who survive
The total number of patients who are alive
Measured: Through study completion, an average of 5 years
Changes in exercise tolerance
Measured by 6-min walk test, which will be done approximately every 3 months at follow up per standard of care
Measured: Baseline to end of the study, an average of 5 years
Changes in supplemental oxygen use severity
Number of patients on supplemental oxygen, which will be recorded approximately every 3 months at follow up per standard of care. This will be compiled at the end of the study to provide overall change in measurement.
Measured: Baseline to end of the study, an average of 5 years
Changes in New York Heart Association (NYHA) functional class
Grading of patients by NYHA functional class, which include functional capacity and objective assessment. This will be compiled at the end of the study to provide overall change in measurement.
Measured: Baseline to end of the study, an average of 5 years
European Quality of Life Five Dimension (EQ-5D) - Scale Score
Assessment of quality of life will be measured using EQ-5D-5L. This instrument is a self-assessed, health-related, quality of life questionnaire that measures quality of life on a 5-component scale. The scores range from Level 1 to Level 5, with lower scores indicating a higher quality of life. This will be collected every 3 months and compiled at the end of the study to provide overall change in measurement.
Measured: Baseline to end of the study, an average of 5 years
Changes in patients' emPHasis-10 scores
Assessed by the emPHasis-10 (pulmonary hypertension) instrument, which is an instrument specifically designed to assess the quality of life in patients with pulmonary hypertension. Each item will be scored from 0 to 5 where 0 was the best score. This will be collected every 3 months and compiled at the end of the study to assess overall change in measurement.
Measured: Baseline to end of the study, an average of 5 years
Number of patients undergoing lung transplantation
Number of patients undergoing lung transplantation
Measured: Baseline to end of the study, an average of 5 years
Secondary outcomes (3)
Changes in CTEPH-/CTED- specific medication
The frequency and dose of medication specifically for management of CTEPH or CTED, which will be assessed approximately every 3 months as routine medical follow up. This will be compiled at the end of the study to assess overall change.
Measured: Baseline to end of the study, an average of 5 years
History of undergoing pulmonary endarterectomy
Number of patients undergoing pulmonary endarterectomy
Measured: Through study completion, an average of 5 years
History of undergoing pulmonary balloon angioplasty
Number of patients undergoing pulmonary balloon angioplasty
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Aug 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miles Conrad, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843500
- Sponsor's protocol ID
- 23-38534
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Thromboembolic Disease: A Prospective Registry
- ClinicalTrials.gov ID
- NCT05843500
- Acronym / sponsor ID
- 23-38534
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 6 May 2023 (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.
The goal of this patient registry is to learn about the natural history in patients with chronic thromboembolic disease (CTD) and/or chronic thromboembolic pulmonary hypertension (CTEPH). The main question[s] it aims to answer are:
- Long-term outcome after various types of treatment, including medication, balloon pulmonary angioplasty, and pulmonary endarterectomy
- Effect of treatment on patient's quality of life and exercise tolerance Participants will be followed longitudinally to assess their health outcomes and quality of life via chart review and health quality surveys.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic thromboembolic disease | – | Other: SurveyPatients with chronic thromboembolic disease/pulmonary hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed chronic thromboembolic disease (CTED) or chronic thromboembolic pulmonary hypertension (CTEPH)
Key inclusion criteria (6 listed)
- Patients referred with CTED and/or CTEPH defined as:
- Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- Main cause of PH other than World Health Organization (WHO) group 4 (CTEPH)
- Patient's refusal to participate in clinical research and/or receive intervention
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 |
|---|---|---|
| SurveyPatients who received medical, surgical or interventional treatment for chronic thromboembolic pulmonary hypertension will be followed and given quality of life questionnaires. | Other | Chronic thromboembolic disease |
Primary outcome
Total number of patients who survive
Time frame: Through study completion, an average of 5 years
The total number of patients who are alive
Changes in exercise tolerance
Time frame: Baseline to end of the study, an average of 5 years
Measured by 6-min walk test, which will be done approximately every 3 months at follow up per standard of care
Changes in supplemental oxygen use severity
Time frame: Baseline to end of the study, an average of 5 years
Number of patients on supplemental oxygen, which will be recorded approximately every 3 months at follow up per standard of care. This will be compiled at the end of the study to provide overall change in measurement.
Changes in New York Heart Association (NYHA) functional class
Time frame: Baseline to end of the study, an average of 5 years
Grading of patients by NYHA functional class, which include functional capacity and objective assessment. This will be compiled at the end of the study to provide overall change in measurement.
European Quality of Life Five Dimension (EQ-5D) - Scale Score
Time frame: Baseline to end of the study, an average of 5 years
Assessment of quality of life will be measured using EQ-5D-5L. This instrument is a self-assessed, health-related, quality of life questionnaire that measures quality of life on a 5-component scale. The scores range from Level 1 to Level 5, with lower scores indicating a higher quality of life. This will be collected every 3 months and compiled at the end of the study to provide overall change in measurement.
Changes in patients' emPHasis-10 scores
Time frame: Baseline to end of the study, an average of 5 years
Assessed by the emPHasis-10 (pulmonary hypertension) instrument, which is an instrument specifically designed to assess the quality of life in patients with pulmonary hypertension. Each item will be scored from 0 to 5 where 0 was the best score. This will be collected every 3 months and compiled at the end of the study to assess overall change in measurement.
Number of patients undergoing lung transplantation
Time frame: Baseline to end of the study, an average of 5 years
Number of patients undergoing lung transplantation
3 secondary outcomes
Changes in CTEPH-/CTED- specific medication
Time frame: Baseline to end of the study, an average of 5 years
History of undergoing pulmonary endarterectomy
Time frame: Through study completion, an average of 5 years
History of undergoing pulmonary balloon angioplasty
Time frame: Through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- 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.
Miles Conrad, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension and Chronic Thromboembolic Disease, run by University of California, San Francisco 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miles Conrad, MD ((415) 353-1300, miles.conrad@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of patients who survive (time frame: Through study completion, an average of 5 years). 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?
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 14 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.