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The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123, an investigational compound which is not approved by the FDA.
Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | BQ-123 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BQ-123 | Drug | 6-120 µg/min |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Vascular Resistance (PVR) | PVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again. | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Vascular Resistance (SVR) | SVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Creager, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BQ-123 | BQ-123 (6-120 µg/min) will be administered intravenously. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BQ-123 | BQ-123 (6-120 µg/min) will be administered intravenously. |
| 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 | Pulmonary Vascular Resistance (PVR) | PVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again. | Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected. | Posted | Mean | Standard Error | dyn*sec/cm^5 | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) |
|
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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 | BQ-123 | BQ-123 (6-120 µg/min) will be administered intravenously. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anju Nohria, MD | Brigham and Women's Hospital | 617-525-6852 | ANOHRIA@PARTNERS.ORG |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D065627 | Familial Primary Pulmonary Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C072247 | cyclo(Trp-Asp-Pro-Val-Leu) |
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| Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) |
| Mean Pulmonary Artery Pressure (PAP) | PAP will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again. | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) |
| Cardiac Output (CO) | CO will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again. | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Systemic Vascular Resistance (SVR) | SVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again. | Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected. | Posted | Mean | Standard Error | dyn*sec/cm^5 | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) |
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| Secondary | Mean Pulmonary Artery Pressure (PAP) | PAP will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again. | Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected. | Posted | Mean | Standard Error | mmHg | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) |
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| Secondary | Cardiac Output (CO) | CO will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again. | Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected. | Posted | Mean | Standard Error | l/min | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) |
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| 0 |
| 38 |
| 0 |
| 38 |
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| D002318 |
| Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|
| Time 4: Normoxia/BQ-123 |
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| Time 5: Hypoxia/BQ-123 |
|
| Title | Measurements |
|---|---|
|
| Time 4: Normoxia/BQ-123 |
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| Time 5: Hypoxia/BQ-123 |
|
| Title | Measurements |
|---|---|
|
| Time 4: Normoxia/BQ-123 |
|
| Time 5: Hypoxia/BQ-123 |
|