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| Name | Class |
|---|---|
| Janssen Pharmaceutica N.V., Belgium | INDUSTRY |
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The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.
Recent presented but unpublished results from trials of BPA vs riociguat for inoperable CTEPH (NCT02634203) have demonstrated that BPA provides a more significant hemodynamic benefit than medical therapy. The investigators hypothesize that participants who are treated with upfront combination medical therapy followed by BPA will have significant improvements in their hemodynamics and RV-PA coupling that can be monitored over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participants with inoperable CTEPH | Active Comparator | subject with inoperable Chronic thromboembolic Pulmonary Hypertension |
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| post PTE residual CTEPH | Active Comparator | Subject with post pulmonary endarterectomy (PTE) residual Chronic Thromboembolic Pulmonary Hypertension |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macitentan Tablets | Drug | 10 mg oral once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in end-systolic elastance (Ees) divided by arterial elastance (Ea) (Ees/Ea) at three time points: Baseline, Timepoint 1 and Timepoint 2. | Ees is a measure of right ventricular (RV) - pulmonary arterial (PA) coupling, with a normal value of Ees/Ea > 0.8 (dimensionless - no units). For subjects with Ees/Ea > 0.8 at the start of the study, we will evaluate the absolute change in Ees/Ea between timepoints. For those with an Ees/Ea < 0.8, we will also determine whether participants have an improvement to > 0.8. | Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in six-minute walk distance (6MWD) in meters. | 6MWD will be determined at baseline, timepoint 1 and timepoint 2. Absolute change between these timepoints will be determined. | Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline) |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the trials:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Salazar | Contact | +1 919 660 2026 | claudia.salazar@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sudarshan Rajagopal, MD, PhD | Duke Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| C533860 | macitentan |
| C542595 | riociguat |
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| Riociguat | Drug | 1 mg to 2.5mg oral three times daily |
|
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| balloon pulmonary angioplasty | Device | on hemodynamics and RV function (including advanced assessments of RV-PA coupling |
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| Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) in picogram/milliliters. | NT-proBNP will be determined at baseline, timepoint 1 and timepoint 2. Absolute change between these timepoints will be determined. | Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline) |
| Change in Cardiac index as measured by liters per minute per meters squared at right heart catheterization. | Right heart catheterization will be performed at baseline, timepoint 1 and timepoint 2 and parameters determined. Absolute change between these timepoints will be determined. | Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline) |
| Change in pulmonary vascular resistance as measured by Wood units at right heart catheterization. | Right heart catheterization will be performed at baseline, timepoint 1 and timepoint 2 and parameters determined. Absolute change between these timepoints will be determined. | Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline) |
| Change in right atrial pressure as measured by millimeters of mercury at right heart catheterization. | Right heart catheterization will be performed at baseline, timepoint 1 and timepoint 2 and parameters determined. Absolute change between these timepoints will be determined. | Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline) |