Chronic Thromboembolic Pulmonary Hypertension (CTEPH)NCT02429284
U.S. CTEPH Registry
An observational study of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Hypertension, run by University of California, San Diego at 1 site in United States.
Trial summary
The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Hypertension
- Type of treatment
- Injection or infusion
- How many people
- 754 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2019
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive consenting patients recently diagnosed (< 6 months) with CTEPH at participating study sites will be enrolled. Patients must meet inclusion criteria and have the diagnosis of CTEPH confirmed by the Adjudication Committee (AC) to be enrolled. Adult and pediatric patients may be enrolled and prior medical therapy will not exclude patients from enrollment.
Who may be able to join
- Patients must be a permanent resident of the United States
- Documentation of the following hemodynamic parameters by right heart catheterization
- Mean pulmonary arterial pressure (PAPm) ≥ 25 mm Hg at rest and,
- Pulmonary artery wedge pressure (PAWP) ≤ 15 mm Hg (or > 15 mmHg if justified)
- Radiologic confirmation that chronic thromboembolic disease is the cause of the pulmonary hypertension by
- One or more mismatched perfusion defect(s) by lung ventilation/perfusion scan, and
Show all 9Show fewer
- Confirmation of chronic thromboembolic disease by evidence of bands/webs, vessel narrowing or occlusion seen on CT pulmonary angiogram (CTA), conventional angiography or MR angiography (MRA).
- Patients must be diagnosed with CTEPH within 6 months of being considered for study eligibility (signing of consent to participate). The date of diagnosis will be defined as when both hemodynamic criteria have been met and chronic thromboembolic disease is confirmed to be the cause of the pulmonary hypertension by an abnormal V/Q scan and the presence of chronic thromboembolic disease on CTA, MRA or pulmonary angiography. Hemodynamic and radiologic criteria can be met at separate time points; the most recently met criteria time point will be defined as the date of diagnosis.
- Prior to enrollment all subjects must have the diagnosis of CTEPH confirmed by the Adjudication Committee.
Who cannot join
- Patients unwilling or unable to provide written consent for participation in the study. Appropriate surrogate consent will be obtained for pediatric patients as defined by each investigational site's IRB.
- Patients with an underlying medical disorder with an anticipated life expectancy less than 2 years.
- Patients who do not meet inclusion criteria including:
- Have not had documentation of hemodynamic criteria by right heart catheterization as outlined in the inclusion criteria
- Do not have radiologic confirmation of chronic thromboembolic disease as outlined in the inclusion criteria
- Meet the criteria for inclusion into WHO Groups I, II, III, or V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: United States CTEPH Registry
The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. The mission of the Registry will be to promote a greater understanding of the prevalence, pathophysiology, evaluation, and treatment of patients with CTEPH through shared information, education, and collaborative investigation among pulmonary hypertension (PH) centers of excellence throughout the U.S.
Read the detailed description
Chronic thromboembolic pulmonary hypertension (CTEPH) is a subset of pulmonary hypertension (PH) characterized by the obstruction of pulmonary arteries with fibrotic material and vascular remodeling that leads to increased pulmonary arterial pressure and right ventricular failure.
A United States CTEPH Registry has been established under the guidance of a Steering Committee consisting of recognized physicians and scientists with expertise in CTEPH and related diseases. The mission of the Registry will be to promote a greater understanding of the prevalence, pathophysiology, evaluation, and treatment of patients with CTEPH through shared information, education, and collaborative investigation among PH centers of excellence throughout the U.S. The development of a national CTEPH registry will be an important element in the advancement of the understanding of CTEPH and improvement in the care of patients who suffer from this debilitating disease.
All consecutive consenting patients recently diagnosed (< 6 months) with CTEPH at participating study sites will be enrolled. At the time of study entry, data on prior history and evaluation will be obtained from patient interview and review of medical records. Patients will be followed biannually after enrollment until the conclusion of the study (minimum of 1 year follow-up for final patients enrolled).
Much of the data gathered by the Registry will be presented as descriptive statistics. The Registry will seek the assistance of a biostatistician to develop a statistical plan for within patient and between patient cohort analyses.
Approximately 750 patients with newly diagnosed (< 6 months) CTEPH will be enrolled.
TIME FRAME:
Participants will be followed from the time of their enrollment until 1 year after the final patient is enrolled. Short term outcome measures and medical history will be collected during the initial visit, and clinical data will be collected from the initial clinic visits, hospital says, or procedures (if applicable). Patients will then be followed every 6 months after their enrollment for long term outcome measures on quality of life, functional status, and medical treatments.
DATA ANALYSES:
Demographics and Clinical Course:
Demographics, risk factors, time to appropriate testing and diagnosis, PAH targeted medication use, functional status, and hemodynamics at the time of enrollment will be provided annually as aggregate data to all investigators.
Evaluating Outcomes of PTE Surgery:
Descriptive statistics of the peri-operative data collected will be provided as aggregate data to all investigators annually. Immediate post-operative and longitudinal follow-up of all patients undergoing PTE surgery will also be provided as aggregate data annually to all sites. Comparisons of hemodynamics, functional status, medication and supplemental oxygen use and healthcare utilization will be made between the pre-operative data and longitudinal post-operative data.
Evaluating Predictors of Successful PTE:
Using longitudinal data collected on post-operative PTE patients, a definition of "successful PTE" will be established based upon hemodynamics, functional status and QoL. Retrospective analysis of pre-, peri-, and post-operative data can then be analyzed to identify factors that predict a "successful" or "unsuccessful" PTE surgery.
Evaluating Outcomes of Nonsurgical Therapy of CTEPH:
Predominantly descriptive statistics will be used to describe why patients are not operative candidates and the nonsurgical therapies (medication, balloon pulmonary angioplasty) used for treatment. Changes in hemodynamics, functional status, QoL and healthcare utilization on therapy will be provided as aggregate data annually.
Evolving Research Needs:
To adapt to the evolving science and research needs of the CTEPH community, separate analysis plans will be developed for new objectives identified and minor changes in the eCRF may occur in response to new diagnostics and treatments, if approved by the Steering Committee. Ongoing assessment of enrollment and data captured will also be performed by the Steering Committee to be certain the goals of the Registry are being met.
COMMITTEES:
A Steering Committee, chaired by Dr. Kim Kerr, is comprised of thought leaders in the areas of cardiology, pulmonology, and cardiothoracic surgery with expertise in CTEPH. The committee will have the following responsibilities:
- Provide advice and guidance on the U.S. CTEPH Registry study design and protocol
- Provide advice and guidance on the variables to be captured by the eCRF
- Provide guidance on study sites selection
- Review data results and provide insights into interpretation of the data annually
- Provide input on the planning and organization of abstracts and manuscripts
- Review abstracts and papers for submission to scientific journals or conferences
- Present data at conferences
An Adjudication Committee, consisting of physicians with expertise in the diagnosis of CTEPH, will review all patients felt by Investigators to be eligible for the Registry. The adjudication committee members must confirm the diagnosis of CTEPH before the subject can be enrolled in the Registry.
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Endarterectomy (PEA), Pulmonary Thromboendarterectomy (PTE), Pulmonary Hypertension, Balloon Pulmonary Angioplasty (BPA)
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients newly diagnosed with CTEPH | Patients newly diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the patterns of evaluation of CTEPH Patients
Measured: up to 5 years
Describe the patters of risk factors and clinical presentation of CTEPH Patients
Measured: up to 5 years
Outcomes of medical and surgical therapy of CTEPH patients as assessed by hemodynamics, quality of life, and functional status
Measured: up to 5 years, at 6 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- 754 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- E Squared Trials and Registries, Inc.
- Responsible party
- Principal investigator, Kim Kerr, University of California, San Diego
- Investigators
- Kim M Kerr, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429284
- Sponsor's protocol ID
- PH-2013-008
- Status last verified
- Mar 2020
- First submitted
- 13 Apr 2015
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim NH, Delcroix M, Jenkins DP, Channick R, Dartevelle P, Jansa P, Lang I, Madani MM, Ogino H, Pengo V, Mayer E. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D92-9. doi: 10.1016/j.jacc.2013.10.024.
PubMed 24355646McGoon MD, Benza RL, Escribano-Subias P, Jiang X, Miller DP, Peacock AJ, Pepke-Zaba J, Pulido T, Rich S, Rosenkranz S, Suissa S, Humbert M. Pulmonary arterial hypertension: epidemiology and registries. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D51-9. doi: 10.1016/j.jacc.2013.10.023.
PubMed 24355642Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
PubMed 21969018Kerr KM, Elliott CG, Chin K, Benza RL, Channick RN, Davis RD, He F, LaCroix A, Madani MM, McLaughlin VV, Park M, Robbins IM, Tapson VF, Terry JR, Test VJ, Jain S, Auger WR. Results From the United States Chronic Thromboembolic Pulmonary Hypertension Registry: Enrollment Characteristics and 1-Year Follow-up. Chest. 2021 Nov;160(5):1822-1831. doi: 10.1016/j.chest.2021.05.052. Epub 2021 Jun 4.
PubMed 34090871Kerr KM, Elliott CG, Benza RL, Channick RN, Chin KM, Davis RD, Jain S, LaCroix AZ, Madani MM, McLaughlin VV, Park MH, Tapson VF, Auger WR. The United States Chronic Thromboembolic Pulmonary Hypertension Registry: Protocol for a Prospective, Longitudinal Study. JMIR Res Protoc. 2021 May 25;10(5):e25397. doi: 10.2196/25397.
PubMed 33848258
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- United States CTEPH Registry
- ClinicalTrials.gov ID
- NCT02429284
- Acronym / sponsor ID
- PH-2013-008
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Endarterectomy (PEA), Pulmonary Thromboendarterectomy (PTE), Pulmonary Hypertension, Balloon Pulmonary Angioplasty (BPA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- E Squared Trials and Registries, Inc.
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 29 Apr 2015 (estimated)
- 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 U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. The mission of the Registry will be to promote a greater understanding of the prevalence, pathophysiology, evaluation, and treatment of patients with CTEPH through shared information, education, and collaborative investigation among pulmonary hypertension (PH) centers of excellence throughout the U.S.
Detailed description
Chronic thromboembolic pulmonary hypertension (CTEPH) is a subset of pulmonary hypertension (PH) characterized by the obstruction of pulmonary arteries with fibrotic material and vascular remodeling that leads to increased pulmonary arterial pressure and right ventricular failure.
A United States CTEPH Registry has been established under the guidance of a Steering Committee consisting of recognized physicians and scientists with expertise in CTEPH and related diseases. The mission of the Registry will be to promote a greater understanding of the prevalence, pathophysiology, evaluation, and treatment of patients with CTEPH through shared information, education, and collaborative investigation among PH centers of excellence throughout the U.S. The development of a national CTEPH registry will be an important element in the advancement of the understanding of CTEPH and improvement in the care of patients who suffer from this debilitating disease.
All consecutive consenting patients recently diagnosed (< 6 months) with CTEPH at participating study sites will be enrolled. At the time of study entry, data on prior history and evaluation will be obtained from patient interview and review of medical records. Patients will be followed biannually after enrollment until the conclusion of the study (minimum of 1 year follow-up for final patients enrolled).
Much of the data gathered by the Registry will be presented as descriptive statistics. The Registry will seek the assistance of a biostatistician to develop a statistical plan for within patient and between patient cohort analyses.
Approximately 750 patients with newly diagnosed (< 6 months) CTEPH will be enrolled.
TIME FRAME:
Participants will be followed from the time of their enrollment until 1 year after the final patient is enrolled. Short term outcome measures and medical history will be collected during the initial visit, and clinical data will be collected from the initial clinic visits, hospital says, or procedures (if applicable). Patients will then be followed every 6 months after their enrollment for long term outcome measures on quality of life, functional status, and medical treatments.
DATA ANALYSES:
Demographics and Clinical Course:
Demographics, risk factors, time to appropriate testing and diagnosis, PAH targeted medication use, functional status, and hemodynamics at the time of enrollment will be provided annually as aggregate data to all investigators.
Evaluating Outcomes of PTE Surgery:
Descriptive statistics of the peri-operative data collected will be provided as aggregate data to all investigators annually. Immediate post-operative and longitudinal follow-up of all patients undergoing PTE surgery will also be provided as aggregate data annually to all sites. Comparisons of hemodynamics, functional status, medication and supplemental oxygen use and healthcare utilization will be made between the pre-operative data and longitudinal post-operative data.
Evaluating Predictors of Successful PTE:
Using longitudinal data collected on post-operative PTE patients, a definition of "successful PTE" will be established based upon hemodynamics, functional status and QoL. Retrospective analysis of pre-, peri-, and post-operative data can then be analyzed to identify factors that predict a "successful" or "unsuccessful" PTE surgery.
Evaluating Outcomes of Nonsurgical Therapy of CTEPH:
Predominantly descriptive statistics will be used to describe why patients are not operative candidates and the nonsurgical therapies (medication, balloon pulmonary angioplasty) used for treatment. Changes in hemodynamics, functional status, QoL and healthcare utilization on therapy will be provided as aggregate data annually.
Evolving Research Needs:
To adapt to the evolving science and research needs of the CTEPH community, separate analysis plans will be developed for new objectives identified and minor changes in the eCRF may occur in response to new diagnostics and treatments, if approved by the Steering Committee. Ongoing assessment of enrollment and data captured will also be performed by the Steering Committee to be certain the goals of the Registry are being met.
COMMITTEES:
A Steering Committee, chaired by Dr. Kim Kerr, is comprised of thought leaders in the areas of cardiology, pulmonology, and cardiothoracic surgery with expertise in CTEPH. The committee will have the following responsibilities:
- Provide advice and guidance on the U.S. CTEPH Registry study design and protocol
- Provide advice and guidance on the variables to be captured by the eCRF
- Provide guidance on study sites selection
- Review data results and provide insights into interpretation of the data annually
- Provide input on the planning and organization of abstracts and manuscripts
- Review abstracts and papers for submission to scientific journals or conferences
- Present data at conferences
An Adjudication Committee, consisting of physicians with expertise in the diagnosis of CTEPH, will review all patients felt by Investigators to be eligible for the Registry. The adjudication committee members must confirm the diagnosis of CTEPH before the subject can be enrolled in the Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients newly diagnosed with CTEPH | – | –Patients newly diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive consenting patients recently diagnosed (< 6 months) with CTEPH at participating study sites will be enrolled. Patients must meet inclusion criteria and have the diagnosis of CTEPH confirmed by the Adjudication Committee (AC) to be enrolled. Adult and pediatric patients may be enrolled and prior medical therapy will not exclude patients from enrollment.
Key inclusion criteria (9 listed)
- Patients must be a permanent resident of the United States
- Documentation of the following hemodynamic parameters by right heart catheterization
- Radiologic confirmation that chronic thromboembolic disease is the cause of the pulmonary hypertension by
- Patients must be diagnosed with CTEPH within 6 months of being considered for study eligibility (signing of consent to participate). The date of diagnosis will be defined as when both hemodynamic criteria have been met and chronic thromboembolic disease is confirmed to be the cause of the pulmonary hypertension by an abnormal V/Q scan and the presence of chronic thromboembolic disease on CTA, MRA or pulmonary angiography. Hemodynamic and radiologic criteria can be met at separate time points; the most recently met criteria time point will be defined as the date of diagnosis.
- Prior to enrollment all subjects must have the diagnosis of CTEPH confirmed by the Adjudication Committee.
Key exclusion criteria (6 listed)
- Patients unwilling or unable to provide written consent for participation in the study. Appropriate surrogate consent will be obtained for pediatric patients as defined by each investigational site's IRB.
- Patients with an underlying medical disorder with an anticipated life expectancy less than 2 years.
- Patients who do not meet inclusion criteria including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the patterns of evaluation of CTEPH Patients
Time frame: up to 5 years
Describe the patters of risk factors and clinical presentation of CTEPH Patients
Time frame: up to 5 years
Outcomes of medical and surgical therapy of CTEPH patients as assessed by hemodynamics, quality of life, and functional status
Time frame: up to 5 years, at 6 month intervals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 24355646Kim NH, Delcroix M, Jenkins DP, Channick R, Dartevelle P, Jansa P, Lang I, Madani MM, Ogino H, Pengo V, Mayer E. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D92-9. doi: 10.1016/j.jacc.2013.10.024.
- Background: PubMed 24355642McGoon MD, Benza RL, Escribano-Subias P, Jiang X, Miller DP, Peacock AJ, Pepke-Zaba J, Pulido T, Rich S, Rosenkranz S, Suissa S, Humbert M. Pulmonary arterial hypertension: epidemiology and registries. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D51-9. doi: 10.1016/j.jacc.2013.10.023.
- Background: PubMed 21969018Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
- Derived from this study: PubMed 34090871Kerr KM, Elliott CG, Chin K, Benza RL, Channick RN, Davis RD, He F, LaCroix A, Madani MM, McLaughlin VV, Park M, Robbins IM, Tapson VF, Terry JR, Test VJ, Jain S, Auger WR. Results From the United States Chronic Thromboembolic Pulmonary Hypertension Registry: Enrollment Characteristics and 1-Year Follow-up. Chest. 2021 Nov;160(5):1822-1831. doi: 10.1016/j.chest.2021.05.052. Epub 2021 Jun 4.
- Derived from this study: PubMed 33848258Kerr KM, Elliott CG, Benza RL, Channick RN, Chin KM, Davis RD, Jain S, LaCroix AZ, Madani MM, McLaughlin VV, Park MH, Tapson VF, Auger WR. The United States Chronic Thromboembolic Pulmonary Hypertension Registry: Protocol for a Prospective, Longitudinal Study. JMIR Res Protoc. 2021 May 25;10(5):e25397. doi: 10.2196/25397.
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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.
Kim M Kerr, MD principal investigator
University of California, San Diego
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 (CTEPH) and Pulmonary Hypertension, run by University of California, San Diego 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 24 Mar 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Describe the patterns of evaluation of CTEPH Patients (time frame: up to 5 years). The study lists 3 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 NCT02429284, which also lists 5 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 24 Mar 2020.