The Role of Endothelin in Pulmonary Hypertension

Phase 2

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: BQ-123

• Registration Number: NCT00759408
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2010-10
• Study Completion: 2011-06
• Results First Submitted: 2017-02-07
• Results First Submitted QC: 2018-09-25
• Results First Posted: 2018-10-24
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Healthy volunteers or known diagnosis of pulmonary hypertension

Exclusion Criteria

• hypertension due to other reasons (not pulmonary)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	BQ-123	BQ-123

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States