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6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosentan | Experimental | 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosentan | Drug | 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acetylcholine Vascular Reactivity Response | Percent pulmonary flow change from baseline after acetylcholine | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intravascular Ultrasound - Pulmonary Artery Wall Thickness | Change in intima-media thickness | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S Celermajer, MBBS, PhD, DSc | Royal Prince Alfred Hospital, Sydney, Australia | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bosentan | 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bosentan | 62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acetylcholine Vascular Reactivity Response | Percent pulmonary flow change from baseline after acetylcholine | Posted | Mean | Standard Deviation | percentage of baseline | Baseline and 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bosentan | 62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof David Celermajer | Royal Prince Alfred Hospital, Sydney, Australia | +61 2 9515 6519 | david.celermajer@email.cs.nsw.gov.au |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Intravascular Ultrasound - Pulmonary Artery Wall Thickness | Change in intima-media thickness | Posted | Mean | Standard Deviation | percentage of baseline | baseline and 6 months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |