Chronic Thromboembolic Pulmonary HypertensionNCT03579862
Identification of Heritable CTEPH
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Some patients who have blood clots come down with a life-threatening condition known as Chronic Thromboembolic Pulmonary Hypertension (CTEPH), which is high blood pressure only in the arteries of the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Blood Draw
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Dec 2013to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CTEPH will be recruited and enrolled at Intermountain Healthcare, also from outside of Intermountain Healthcare, for example at the University of Utah (following IRB approval there) and at national conferences.
Who may be able to join
- CTEPH cohort:
- Confirmed CTEPH based on having undergone PEA surgery.
- Strongly suspected CTEPH based on right heart catheterization data showing mPAP>26 and PCWP<15, and imaging demonstrating chronic thromboembolic disease (either ventilation/perfusion scan, CT pulmonary angiography, or conventional pulmonary angiography).
- PE cohort:
- PE diagnosed by CT pulmonary angiography or ventilation/perfusion scan within the preceding 24 months.
- No evidence of PH at the time of enrollment (based on absence of dyspnea, exertional chest pain, or exertional presyncope on history, lack of physical exam findings of PH or right heart failure, and lack of signs of PH on objective data including echocardiography and/or right heart catheterization).
Show all 12Show fewer
- No evidence of chronic thromboembolic disease at the time of enrollment (based on chronic appearing thrombus on CT pulmonary angiography or conventional pulmonary angiography, or based on prior high probability ventilation/perfusion scan showing a similar pattern of perfusion defects).
- PAH cohort:
- Diagnosis of group 1 PAH.
- Prior normal or low probability ventilation/perfusion scan.
- No reported history of prior VTE events.
- If available, all prior evaluations for VTE (including CT pulmonary angiography and Doppler ultrasound exams) must also be negative.
Who cannot join
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Valerie T Aston, MBA, 801-507-4606, valerie.aston@imail.org
David P Tomer, MS, 801-507-4694, david.tomer@imail.org
About this study
Official title: Identification and Molecular Characterization of Heritable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Some patients who have blood clots come down with a life-threatening condition known as Chronic Thromboembolic Pulmonary Hypertension (CTEPH), which is high blood pressure only in the arteries of the lungs. This study seeks to understand more about the genetics causes of CTEPH by obtaining blood samples and examining family histories.
Read the detailed description
This project proposes to identify a cohort of Utah patients with CTEPH, and to perform a comprehensive analysis of family history and CTEPH risk factors in these patients, and in controls with acute pulmonary embolism (PE) and pulmonary arterial hypertension (PAH). Detailed family history interviews will be performed with all patients, and all enrolled patients will provide a blood sample for thrombophilia testing and for gene sequencing with the goal of identifying novel genetic variants that contribute to CTEPH risk.
- Being tested
- Blood Draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
| Study group | Role | What they receive |
|---|---|---|
| Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Not described Receives: Other: Blood Draw | |
| Pulmonary Embolism (PE) | Not described Receives: Other: Blood Draw | |
| Pulmonary Arterial Hypertension (PAH) | Not described Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of family history of VTE in relatives of CTEPH patients compared to PE and PAH patients in Intermountain populations
Measured: through study completion, approximately 18 months
Secondary outcomes (5)
Characteristics of familial and, apparently, sporadic CTEPH in Intermountain populations
Measured: through study completion, approximately 18 months
Estimates of prevalence of familial CTEPH in Intermountain populations
Measured: through study completion, approximately 18 months
Heritability and penetrance patterns of familial CTEPH
Measured: through study completion, approximately 18 months
Discovery and validation of genetic polymorphisms present in familial CTEPH patients
Measured: through study completion, approximately 18 months
Identification of gene pathways that may be relevant to the development of CTEPH after actue PE
Measured: through study completion, approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start25 Dec 2013
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Dodson, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579862
- Sponsor's protocol ID
- 1024723
- Status last verified
- Oct 2022
- First submitted
- 24 May 2018
- Last updated
- 18 Oct 2022
- 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Molecular Characterization of Heritable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- ClinicalTrials.gov ID
- NCT03579862
- Acronym / sponsor ID
- 1024723
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 25 Dec 2013 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jul 2018 (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.
Some patients who have blood clots come down with a life-threatening condition known as Chronic Thromboembolic Pulmonary Hypertension (CTEPH), which is high blood pressure only in the arteries of the lungs. This study seeks to understand more about the genetics causes of CTEPH by obtaining blood samples and examining family histories.
Detailed description
This project proposes to identify a cohort of Utah patients with CTEPH, and to perform a comprehensive analysis of family history and CTEPH risk factors in these patients, and in controls with acute pulmonary embolism (PE) and pulmonary arterial hypertension (PAH). Detailed family history interviews will be performed with all patients, and all enrolled patients will provide a blood sample for thrombophilia testing and for gene sequencing with the goal of identifying novel genetic variants that contribute to CTEPH risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | – | Other: Blood Draw |
| Pulmonary Embolism (PE) | – | Other: Blood Draw |
| Pulmonary Arterial Hypertension (PAH) | – | Other: Blood Draw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CTEPH will be recruited and enrolled at Intermountain Healthcare, also from outside of Intermountain Healthcare, for example at the University of Utah (following IRB approval there) and at national conferences.
Key inclusion criteria (12 listed)
- CTEPH cohort:
- PE cohort:
- PAH cohort:
Key exclusion criteria (1 listed)
- Under the age of 18
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 |
|---|---|---|
| Blood Draw | Other | Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Arterial Hypertension (PAH), Pulmonary Embolism (PE) |
Primary outcome
Rates of family history of VTE in relatives of CTEPH patients compared to PE and PAH patients in Intermountain populations
Time frame: through study completion, approximately 18 months
5 secondary outcomes
Characteristics of familial and, apparently, sporadic CTEPH in Intermountain populations
Time frame: through study completion, approximately 18 months
Estimates of prevalence of familial CTEPH in Intermountain populations
Time frame: through study completion, approximately 18 months
Heritability and penetrance patterns of familial CTEPH
Time frame: through study completion, approximately 18 months
Discovery and validation of genetic polymorphisms present in familial CTEPH patients
Time frame: through study completion, approximately 18 months
Identification of gene pathways that may be relevant to the development of CTEPH after actue PE
Time frame: through study completion, approximately 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Chronic Thromboembolic Pulmonary Hypertension
Active, not recruitingObservational study
TrEatment Approach in the Multimodal Era Registry
Chronic Thromboembolic Pulmonary Hypertension, CTEPH
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
RecruitingObservational study
Safety and Efficacy of Balloon Pulmonary Angioplasty in China
Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Quality of Life Questionnaire in Pulmonary Hypertension EMPHASIS-10: Brazilian Adaptation and Validation
Pulmonary Hypertension, Quality of Life
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.
Mark Dodson, MD principal investigator
Intermountain Health Care, Inc.
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, run by Intermountain Health Care, Inc. 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 12 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie T Aston, MBA (801-507-4606, valerie.aston@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of family history of VTE in relatives of CTEPH patients compared to PE and PAH patients in Intermountain populations (time frame: through study completion, approximately 18 months). 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 18 Oct 2022.