Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty
NCT ID: NCT03409588
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2018-06-13
2026-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study Drug
Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication
Adempas
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.
Interventions
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Adempas
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* able to give consent
* able to perform a exercise protocol
Exclusion Criteria
* ongoing PAH-specific vasodilator therapy
* known contraindication to riociguat
* a physical limitation to completing an exercise protocol
18 Years
100 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Todd Bull, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Peter Sottile, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
William Cornwell, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Other Identifiers
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17-2349
Identifier Type: -
Identifier Source: org_study_id
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