Pulmonary Hypertension
Conditions
Keywords
primary pulmonary hypertension, secondary pulmonary hypertension due to left heart failure, secondary pulmonary hypertension due to other causes, patients without pulmonary disease or pulmonary hypertension
Brief summary
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.
Detailed description
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.
Interventions
DRUGBQ-123
6-120 µg/min
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers or known diagnosis of pulmonary hypertension
Exclusion criteria
* hypertension due to other reasons (not pulmonary)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Vascular Resistance (PVR) | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Vascular Resistance (SVR) | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) | 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. |
| Mean Pulmonary Artery Pressure (PAP) | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) | 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. |
| Cardiac Output (CO) | Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BQ-123 BQ-123 (6-120 µg/min) will be administered intravenously. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | BQ-123 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
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.
Time frame: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Population: Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BQ-123 | Pulmonary Vascular Resistance (PVR) | Baseline | 64 dyn*sec/cm^5 | Standard Error 5 |
| BQ-123 | Pulmonary Vascular Resistance (PVR) | Time 2: Hypoxia | 119 dyn*sec/cm^5 | Standard Error 10 |
| BQ-123 | Pulmonary Vascular Resistance (PVR) | Time 3: Normoxia | 67 dyn*sec/cm^5 | Standard Error 5 |
| BQ-123 | Pulmonary Vascular Resistance (PVR) | Time 4: Normoxia/BQ-123 | 46 dyn*sec/cm^5 | Standard Error 5 |
| BQ-123 | Pulmonary Vascular Resistance (PVR) | Time 5: Hypoxia/BQ-123 | 85 dyn*sec/cm^5 | Standard Error 9 |
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.
Time frame: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Population: Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BQ-123 | Cardiac Output (CO) | Time 4: Normoxia/BQ-123 | 6.4 l/min | Standard Error 0.3 |
| BQ-123 | Cardiac Output (CO) | Baseline | 5.3 l/min | Standard Error 0.3 |
| BQ-123 | Cardiac Output (CO) | Time 2: Hypoxia | 6.7 l/min | Standard Error 0.4 |
| BQ-123 | Cardiac Output (CO) | Time 3: Normoxia | 5.2 l/min | Standard Error 0.3 |
| BQ-123 | Cardiac Output (CO) | Time 5: Hypoxia/BQ-123 | 8.3 l/min | Standard Error 0.6 |
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.
Time frame: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Population: Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BQ-123 | Mean Pulmonary Artery Pressure (PAP) | Baseline | 10 mmHg | Standard Error 1 |
| BQ-123 | Mean Pulmonary Artery Pressure (PAP) | Time 2: Hypoxia | 15 mmHg | Standard Error 1 |
| BQ-123 | Mean Pulmonary Artery Pressure (PAP) | Time 3: Normoxia | 10 mmHg | Standard Error 1 |
| BQ-123 | Mean Pulmonary Artery Pressure (PAP) | Time 4: Normoxia/BQ-123 | 9 mmHg | Standard Error 1 |
| BQ-123 | Mean Pulmonary Artery Pressure (PAP) | Time 5: Hypoxia/BQ-123 | 14 mmHg | Standard Error 1 |
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.
Time frame: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Population: Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BQ-123 | Systemic Vascular Resistance (SVR) | Baseline | 1368 dyn*sec/cm^5 | Standard Error 52 |
| BQ-123 | Systemic Vascular Resistance (SVR) | Time 2: Hypoxia | 1050 dyn*sec/cm^5 | Standard Error 57 |
| BQ-123 | Systemic Vascular Resistance (SVR) | Time 3: Normoxia | 1351 dyn*sec/cm^5 | Standard Error 44 |
| BQ-123 | Systemic Vascular Resistance (SVR) | Time 4: Normoxia/BQ-123 | 1069 dyn*sec/cm^5 | Standard Error 38 |
| BQ-123 | Systemic Vascular Resistance (SVR) | Time 5: Hypoxia/BQ-123 | 828 dyn*sec/cm^5 | Standard Error 43 |