CTEPHNCT06105242
Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
An observational study of CTEPH, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
1. To identify biological sex differences in baseline RV function in CTEPH 2. To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH 3. To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CTEPH
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2022to 31 Dec 2026
- How long will I take part?
- 6 Months
- 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: Participants with right ventricular failure
Who may be able to join
- Adult (≥18 years old) patients diagnosed with CTEPH per current guideline standard42
- Subject must have a baseline TTE (within 3 months of diagnosis) with adequate images for RVGLS analysis
- Subject must have a right heart catheterization (RHC) at the time of diagnosis
- To be included in the Aim 2 analysis, patients must undergo PTE surgery and have a TTE performed 3-9 months after surgery with adequate images for RVGLS strain analysis
Who cannot join
- Unclear or mixed PH diagnosis as designated by an expert clinician at Intermountain PH center
- Any subjects <18 years of age
- Patients diagnosed during pregnancy
- Patients without a TTE and RHC at time of diagnosis
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
Intermountain Medical Center
Murray, Utah, 84107
Valerie Aston, 801-507-4606, valerie.aston@imail.org
Darrin Applegate, 801-507-4814, darrin.applegate@imail.org
About this study
Official title: Biological Sex and Sex Hormones Moderate Right Ventricular (RV) Dysfunction and Recovery in Chronic Thromboembolic Pulmonary Hypertension
- To identify biological sex differences in baseline RV function in CTEPH
- To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH
- To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.
Read the detailed description
Aims 1 and 2 together comprise a retrospective cohort study. We will identify historical subjects with newly diagnosed CTEPH using a clinical database. We will perform TTE strain analysis (RVGLS) to compare RV function between the biologic sexes at diagnosis and after surgical correction of CTEPH (to assess recovery).
- Conditions
- CTEPH
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 |
|---|---|---|
| Retrospective Cohort Aim 1 | Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol. | |
| Retrospective Cohort Aim 2 | Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol. | |
| Prospective Cohort Aim 3 | Aim 3 is prospective and will enroll a distinct set of patients from Aim 1 and 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biosphere
To assess biological sex differences in baseline RV function in CTEPH
Measured: 1 year
Biopshere
To determine the biological sex differences in recovery of RV function after PTE surgery in CTEPH
Measured: 1 year
Biosphere
To assess if and how sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start30 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTEPHStudies 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
- 10 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105242
- Sponsor's protocol ID
- 1051738
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Sex and Sex Hormones Moderate Right Ventricular (RV) Dysfunction and Recovery in Chronic Thromboembolic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06105242
- Acronym / sponsor ID
- 1051738
- Conditions
- CTEPH
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Oct 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.
- To identify biological sex differences in baseline RV function in CTEPH
- To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH
- To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.
Detailed description
Aims 1 and 2 together comprise a retrospective cohort study. We will identify historical subjects with newly diagnosed CTEPH using a clinical database. We will perform TTE strain analysis (RVGLS) to compare RV function between the biologic sexes at diagnosis and after surgical correction of CTEPH (to assess recovery).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort Aim 1 | – | –Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol. |
| Retrospective Cohort Aim 2 | – | –Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol. |
| Prospective Cohort Aim 3 | – | –Aim 3 is prospective and will enroll a distinct set of patients from Aim 1 and 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with right ventricular failure
Key inclusion criteria (4 listed)
- Adult (≥18 years old) patients diagnosed with CTEPH per current guideline standard42
- Subject must have a baseline TTE (within 3 months of diagnosis) with adequate images for RVGLS analysis
- Subject must have a right heart catheterization (RHC) at the time of diagnosis
- To be included in the Aim 2 analysis, patients must undergo PTE surgery and have a TTE performed 3-9 months after surgery with adequate images for RVGLS strain analysis
Key exclusion criteria (4 listed)
- Unclear or mixed PH diagnosis as designated by an expert clinician at Intermountain PH center
- Any subjects <18 years of age
- Patients diagnosed during pregnancy
- Patients without a TTE and RHC at time of diagnosis
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
Biosphere
Time frame: 1 year
To assess biological sex differences in baseline RV function in CTEPH
Biopshere
Time frame: 1 year
To determine the biological sex differences in recovery of RV function after PTE surgery in CTEPH
Biosphere
Time frame: 1 year
To assess if and how sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.
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 27 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for CTEPH
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Early Detection of CTEPH in Patients After APE
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The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
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A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
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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.
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 CTEPH, 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 4 inclusion and 4 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 27 Oct 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biosphere (time frame: 1 year). 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?
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 27 Oct 2023.