The Role of Endothelin in Pulmonary Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Role of Endothelin in Pulmonary Hypertension

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Drug: BQ-123


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers or known diagnosis of pulmonary hypertension Exclusion Criteria: hypertension due to other reasons (not pulmonary)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BQ-123 | Drug: BQ-123<br>* 6-120 µg/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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