Chronic Thromboembolic Disease (CTED), Exercise Intolerance Post PEA Surgery
Conditions
Keywords
Chronic Thromboembolic Disease, CTED, Treatment Post PEA surgery
Brief summary
This is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA).
Interventions
DRUGAdempas
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.
Sponsors
University of Colorado, Denver
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean pulmonary arterial pressure | Baseline and 3 months | Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC) |
| Change in cardiac output | Baseline and 3 months | Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC) |
| Change in Pulmonary artery compliance | Baseline and 3 months | Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 minute walk test | Baseline and 3 months | Measurements include change in 6 minute walk test (6 MWT) following 3 months of study drug |
| Change in New York Heart Association (NYHA) functional class | Baseline and 3 months | Measurements include Change in New York Heart Association (NYHA) functional class following 3 months of study drug |
| Change in the University of California San Diego (UCSD) shortness of Breath Score | Baseline and 3 months | Measurements include: Change in the University of California San Diego (UCSD) shortness of Breath Score following 3 months of study drug |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTodd Bull, MD
University of Colorado, Denver
PRINCIPAL_INVESTIGATORPeter Sottile, MD
University of Colorado, Denver
PRINCIPAL_INVESTIGATORWilliam Cornwell, MD
University of Colorado, Denver
Outcome results
None listed