Chronic Thromboembolic Disease (CTED)Phase 2NCT03409588
Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty
A Phase 2 study testing Adempas in people with Chronic Thromboembolic Disease (CTED) and Exercise Intolerance Post PEA Surgery, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Thromboembolic Disease (CTED), Exercise Intolerance Post PEA Surgery
- What is being tested?
- Adempas
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 26 Jan 2026
- Phase
- Phase 2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who underwent PTE or BPA for Chronic thromboembolic pulmonary hypertension (CTEPH) at least six months prior to screening and report ongoing subjective exercise limitation,
- able to give consent
- able to perform a exercise protocol
Who cannot join
- Patients with known Residual Pulmonary Hypertension (RPH) by RHC following PTE for CTEPH
- ongoing PAH-specific vasodilator therapy
- known contraindication to riociguat
- a physical limitation to completing an exercise protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy
This is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA).
- Being tested
- Adempas
- Keywords
- Chronic Thromboembolic Disease, CTED, Treatment Post PEA surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdempasDrug
Also called Riociguat
After obtaining baseline data, patients will be placed on oral riociguat at a dose of 0.5 mg TID which will be up titrated over two months to a maximum dose of 2.5 mg TID or maximum tolerated dose. After 3 months from onset of riociguat initiation, the University of California San Diego (UCSD) shortness of breath score, 6 Minute Walk Test (6MWD), and resting/exercise Right Heart Catheterization (RHC) will be repeated.
| Study group | Role | What they receive |
|---|---|---|
| Study Drug | Experimental | Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication Receives: Drug: Adempas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean pulmonary arterial pressure
Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)
Measured: Baseline and 3 months
Change in cardiac output
Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)
Measured: Baseline and 3 months
Change in Pulmonary artery compliance
Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)
Measured: Baseline and 3 months
Secondary outcomes (3)
Change in 6 minute walk test
Measurements include change in 6 minute walk test (6 MWT) following 3 months of study drug
Measured: Baseline and 3 months
Change in New York Heart Association (NYHA) functional class
Measurements include Change in New York Heart Association (NYHA) functional class following 3 months of study drug
Measured: Baseline and 3 months
Change in the University of California San Diego (UCSD) shortness of Breath Score
Measurements include: Change in the University of California San Diego (UCSD) shortness of Breath Score following 3 months of study drug
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start13 Jun 2018
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Disease (CTED)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Todd Bull, MD, Principal investigator, University of Colorado, DenverPeter Sottile, MD, Principal investigator, University of Colorado, DenverWilliam Cornwell, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409588
- Sponsor's protocol ID
- 17-2349
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2018
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy
- ClinicalTrials.gov ID
- NCT03409588
- Acronym / sponsor ID
- 17-2349
- Keywords
- Chronic Thromboembolic Disease, CTED, Treatment Post PEA surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 24 Jan 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 is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Drug | Experimental | Drug: AdempasRiociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients who underwent PTE or BPA for Chronic thromboembolic pulmonary hypertension (CTEPH) at least six months prior to screening and report ongoing subjective exercise limitation,
- able to give consent
- able to perform a exercise protocol
Key exclusion criteria (4 listed)
- Patients with known Residual Pulmonary Hypertension (RPH) by RHC following PTE for CTEPH
- ongoing PAH-specific vasodilator therapy
- known contraindication to riociguat
- a physical limitation to completing an exercise protocol
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 |
|---|---|---|
| AdempasAlso: RiociguatAfter obtaining baseline data, patients will be placed on oral riociguat at a dose of 0.5 mg TID which will be up titrated over two months to a maximum dose of 2.5 mg TID or maximum tolerated dose. After 3 months from onset of riociguat initiation, the University of California San Diego (UCSD) shortness of breath score, 6 Minute Walk Test (6MWD), and resting/exercise Right Heart Catheterization (RHC) will be repeated. | Drug | Study Drug |
Primary outcome
Change in mean pulmonary arterial pressure
Time frame: Baseline and 3 months
Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)
Change in cardiac output
Time frame: Baseline and 3 months
Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)
Change in Pulmonary artery compliance
Time frame: Baseline and 3 months
Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)
3 secondary outcomes
Change in 6 minute walk test
Time frame: Baseline and 3 months
Change in New York Heart Association (NYHA) functional class
Time frame: Baseline and 3 months
Change in the University of California San Diego (UCSD) shortness of Breath Score
Time frame: Baseline and 3 months
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 5 Feb 2026.
- Individual participant dataSharing planned: No
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.
Todd Bull, MD principal investigator
University of Colorado, Denver
Peter Sottile, MD principal investigator
University of Colorado, Denver
William Cornwell, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adempas in people with Chronic Thromboembolic Disease (CTED) and Exercise Intolerance Post PEA Surgery, run by University of Colorado, Denver 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 3 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: finished, as of the sponsor's last update on 5 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in mean pulmonary arterial pressure (time frame: Baseline and 3 months). 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 5 Feb 2026.