Chronic Thromboembolic Pulmonary HypertensionPREDICT PHNCT03470207
The Prospective Risk Factor Evaluation & Discovery In CTEPH Study
A study testing Post-pulmonary embolism follow up protocol in people with Chronic Thromboembolic Pulmonary Hypertension, run by Mark W. Dodson at 1 site in United States.
Trial summary
This research study wants to find markers in the blood that may help to predict a patient's future risk of developing a disease called CTEPH. The study also wants to see if active monitoring for signs and symptoms of CTEPH after a pulmonary embolism (a blood clot in the lungs) can improve the diagnosis of CTEPH. 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?
- Post-pulmonary embolism follow up protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to Aug 2021
- 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
- Age ≥ 18 years.
- Presence of pulmonary embolism (PE) objectively diagnosed by ventilation/perfusion (V/Q) scan or computed tomography pulmonary angiography (CTPA).
- Plus one of:
- Prior history of PE before the index event (predicted 2-year incidence of chronic thromboembolic pulmonary hypertension (CTEPH) of 35%).
- Transthoracic echocardiogram (TTE) performed within 72 hours of PE diagnosis demonstrating a maximum velocity of the tricuspid regurgitant (TR) jet ≥ 3.0 meters/second (predicted 2-year incidence of CTEPH of approximately 25%).
- CTPA demonstrating involvement of one of the main pulmonary arteries with PE (predicted 2-year incidence of CTEPH of approximately 15%).
- CTEPH prediction score ≥ 6 (this score is based on several clinical factors, including unprovoked nature of the PE, presence of right ventricular dysfunction by CTPA or TTE, presence of hypothyroidism or diabetes, and thrombolytic therapy for PE).
Who cannot join
- The patient previously met diagnostic criteria for pulmonary hypertension of any cause.
- Presence of significant left ventricular systolic dysfunction (defined by left ventricular ejection fraction ≤ 45% by TTE), or left sided valvular disease (including mitral or aortic regurgitation or stenosis).
- Age > 85 years.
- The presence of metastatic malignancy (due to the expected limitation of lifespan to less than the study follow-up period of 2 years).
- The presence of a significant psychiatric disorder or significant cognitive impairment, which would make follow-up and/or symptom reporting difficult.
- Inability or unwillingness to attend follow-up clinic appointments at Intermountain Medical Center (including geographical, financial, and insurance limitations).
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: The Prospective Risk Factor Evaluation and Discovery In Chronic Thromboembolic Pulmonary Hypertension Study
This research study wants to find markers in the blood that may help to predict a patient's future risk of developing a disease called CTEPH. The study also wants to see if active monitoring for signs and symptoms of CTEPH after a pulmonary embolism (a blood clot in the lungs) can improve the diagnosis of CTEPH.
Patients who enroll in this study will have periodic blood draws and clinic and/or phone follow-up to monitor for signs and symptoms of CTEPH. Patients' medical records will also be reviewed for information related to pulmonary embolisms and/or CTEPH.
Read the detailed description
Chronic thromboembolic pulmonary hypertension (CTEPH) is due to non-resolution of pulmonary embolism (PE), and is the most serious long-term sequela of PE. Without treatment, CTEPH leads to progressive right heart failure and death. Fortunately, most cases of CTEPH are potentially curable by a surgical procedure in which the chronic thromboembolic material is removed from the pulmonary arterial tree, and for those who are not surgical candidates a novel medical therapy is now available. Multiple studies have shown, however, that the majority of CTEPH cases go undiagnosed, and thus many symptomatic patients are never offered these potentially beneficial treatments. Because persistent dyspnea affects up to 50% of patients who survive an acute PE, selecting which patients should undergo further invasive testing for CTEPH is a difficult clinical problem. In this study, the investigators propose to prospectively follow a cohort of high-risk patients after acute PE until CTEPH is either diagnosed or excluded, and perform serial collection and banking of biospecimens that will allow for prospective and longitudinal screening of biomarkers that might predict future risk of CTEPH. Biomarker screening will initially be focused on a panel of 20 pre-specified plasma proteins with roles in coagulation/fibrinolysis or inflammation, as well as assays of fibrinolysis, as these are processes that existing literature suggests are linked to the pathophysiology of CTEPH. The biorepository created for this study could also be used in the future to perform unbiased screening with proteomic techniques or RNAseq in the hopes of identifying novel biomarkers and novel biological processes that are relevant to the development of CTEPH. As there is no current consensus as to whether structured follow-up after PE to detect signs and symptoms of CTEPH is beneficial, this study also includes an analysis of whether a novel structured follow-up program improves identification of incident CTEPH cases. This study has the potential to dramatically improve post-PE care by facilitating stratification of patients by future risk of CTEPH at the time of acute PE, thus allowing for expert follow-up to be tailored to those patients at highest risk for CTEPH. The investigators hope that these efforts will improve the rate at which CTEPH cases are identified, so that more patients can benefit from existing treatments.
- Being tested
- Post-pulmonary embolism follow up protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-pulmonary embolism follow up protocolProcedure or surgery
Structured post-pulmonary embolism follow up protocol (outlined in Aim 1)
| Study group | Role | What they receive |
|---|---|---|
| Post-Intervention Cohort (Aim 1) | No intervention | This arm will not have the intervention of the implementation of the structured post-pulmonary embolism follow up protocol that is outlined in Aim 1. |
| Pre-Intervention Cohort (Aim 3) | Experimental | This arm will have the intervention of the implementation of the structured post-pulmonary embolism follow up protocol that is outlined in Aim 1. Receives: Procedure: Post-pulmonary embolism follow up protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) diagnosis rate
Number of CTEPH diagnoses divided by number of patients in each cohort (pre- and post-intervention)
Measured: Day of diagnosis of pulmonary embolism (PE) until 2 years after day of diagnosis of PE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start17 Apr 2018
- Primary completionMay 2021 (estimated)
- Study completionAug 2021 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark W. Dodson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark W. Dodson, Intermountain Health Care, Inc.
- Investigators
- Mark W Dodson, MD PhD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470207
- Sponsor's protocol ID
- 1050516
- Acronym
- PREDICT PH
- Status last verified
- May 2019
- First submitted
- 12 Mar 2018
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per the consent: "The scientific results from this study may be reported at scientific discussions or published in medical journals. You will not be identified personally in any presentation or published report." "If your samples and data are shared with researchers at other hospitals and institutions outside of Intermountain Healthcare, they will be labeled with a de-identified code so that researchers outside of Intermountain Healthcare will not be able to identify you."
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Risk Factor Evaluation and Discovery In Chronic Thromboembolic Pulmonary Hypertension Study
- ClinicalTrials.gov ID
- NCT03470207
- Acronym / sponsor ID
- PREDICT PH / 1050516
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Mark W. DodsonUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 19 Mar 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.
This research study wants to find markers in the blood that may help to predict a patient's future risk of developing a disease called CTEPH. The study also wants to see if active monitoring for signs and symptoms of CTEPH after a pulmonary embolism (a blood clot in the lungs) can improve the diagnosis of CTEPH.
Patients who enroll in this study will have periodic blood draws and clinic and/or phone follow-up to monitor for signs and symptoms of CTEPH. Patients' medical records will also be reviewed for information related to pulmonary embolisms and/or CTEPH.
Detailed description
Chronic thromboembolic pulmonary hypertension (CTEPH) is due to non-resolution of pulmonary embolism (PE), and is the most serious long-term sequela of PE. Without treatment, CTEPH leads to progressive right heart failure and death. Fortunately, most cases of CTEPH are potentially curable by a surgical procedure in which the chronic thromboembolic material is removed from the pulmonary arterial tree, and for those who are not surgical candidates a novel medical therapy is now available. Multiple studies have shown, however, that the majority of CTEPH cases go undiagnosed, and thus many symptomatic patients are never offered these potentially beneficial treatments. Because persistent dyspnea affects up to 50% of patients who survive an acute PE, selecting which patients should undergo further invasive testing for CTEPH is a difficult clinical problem. In this study, the investigators propose to prospectively follow a cohort of high-risk patients after acute PE until CTEPH is either diagnosed or excluded, and perform serial collection and banking of biospecimens that will allow for prospective and longitudinal screening of biomarkers that might predict future risk of CTEPH. Biomarker screening will initially be focused on a panel of 20 pre-specified plasma proteins with roles in coagulation/fibrinolysis or inflammation, as well as assays of fibrinolysis, as these are processes that existing literature suggests are linked to the pathophysiology of CTEPH. The biorepository created for this study could also be used in the future to perform unbiased screening with proteomic techniques or RNAseq in the hopes of identifying novel biomarkers and novel biological processes that are relevant to the development of CTEPH. As there is no current consensus as to whether structured follow-up after PE to detect signs and symptoms of CTEPH is beneficial, this study also includes an analysis of whether a novel structured follow-up program improves identification of incident CTEPH cases. This study has the potential to dramatically improve post-PE care by facilitating stratification of patients by future risk of CTEPH at the time of acute PE, thus allowing for expert follow-up to be tailored to those patients at highest risk for CTEPH. The investigators hope that these efforts will improve the rate at which CTEPH cases are identified, so that more patients can benefit from existing treatments.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Intervention Cohort (Aim 1) | No intervention | –This arm will not have the intervention of the implementation of the structured post-pulmonary embolism follow up protocol that is outlined in Aim 1. |
| Pre-Intervention Cohort (Aim 3) | Experimental | Procedure: Post-pulmonary embolism follow up protocolThis arm will have the intervention of the implementation of the structured post-pulmonary embolism follow up protocol that is outlined in Aim 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Presence of pulmonary embolism (PE) objectively diagnosed by ventilation/perfusion (V/Q) scan or computed tomography pulmonary angiography (CTPA).
- Plus one of:
- Prior history of PE before the index event (predicted 2-year incidence of chronic thromboembolic pulmonary hypertension (CTEPH) of 35%).
- Transthoracic echocardiogram (TTE) performed within 72 hours of PE diagnosis demonstrating a maximum velocity of the tricuspid regurgitant (TR) jet ≥ 3.0 meters/second (predicted 2-year incidence of CTEPH of approximately 25%).
Key exclusion criteria (6 listed)
- The patient previously met diagnostic criteria for pulmonary hypertension of any cause.
- Presence of significant left ventricular systolic dysfunction (defined by left ventricular ejection fraction ≤ 45% by TTE), or left sided valvular disease (including mitral or aortic regurgitation or stenosis).
- Age > 85 years.
- The presence of metastatic malignancy (due to the expected limitation of lifespan to less than the study follow-up period of 2 years).
- The presence of a significant psychiatric disorder or significant cognitive impairment, which would make follow-up and/or symptom reporting difficult.
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 |
|---|---|---|
| Post-pulmonary embolism follow up protocolStructured post-pulmonary embolism follow up protocol (outlined in Aim 1) | Procedure or surgery | Pre-Intervention Cohort (Aim 3) |
Primary outcome
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) diagnosis rate
Time frame: Day of diagnosis of pulmonary embolism (PE) until 2 years after day of diagnosis of PE
Number of CTEPH diagnoses divided by number of patients in each cohort (pre- and post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Individual participant dataSharing planned: Yes. Per the consent: "The scientific results from this study may be reported at scientific discussions or published in medical journals. You will not be identified personally in any presentation or published report." "If your samples and data are shared with researchers at other hospitals and institutions outside of Intermountain Healthcare, they will be labeled with a de-identified code so that researchers outside of Intermountain Healthcare will not be able to identify you."
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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.
Mark W Dodson, MD PhD 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?
A study testing Post-pulmonary embolism follow up protocol in people with Chronic Thromboembolic Pulmonary Hypertension, run by Mark W. Dodson 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 7 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: status not confirmed, as of the sponsor's last update on 17 May 2019. 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?
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) diagnosis rate (time frame: Day of diagnosis of pulmonary embolism (PE) until 2 years after day of diagnosis of PE). 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 17 May 2019; AzTrials last refreshed its copy on 3 Nov 2026.