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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug | Experimental | Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adempas | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean pulmonary arterial pressure | Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC) | Baseline and 3 months |
| Change in cardiac output | Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC) | Baseline and 3 months |
| Change in Pulmonary artery compliance | Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC) | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 minute walk test | Measurements include change in 6 minute walk test (6 MWT) following 3 months of study drug | Baseline and 3 months |
| Change in New York Heart Association (NYHA) functional class |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Bull, MD | University of Colorado, Denver | Principal Investigator |
| Peter Sottile, MD | University of Colorado, Denver | Principal Investigator |
| William Cornwell, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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Measurements include Change in New York Heart Association (NYHA) functional class following 3 months of study drug
| 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 | Baseline and 3 months |
| ID | Term |
|---|---|
| C542595 | riociguat |
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