Back to resultsThe Role of Endothelin in Pulmonary Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BQ-123
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers or known diagnosis of pulmonary hypertension
Exclusion Criteria:
- hypertension due to other reasons (not pulmonary)
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
BQ-123
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT00759408
First Posted
September 24, 2008
Last Updated
November 1, 2018
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00759408
Brief Title
The Role of Endothelin in Pulmonary Hypertension
Official Title
The Role of Endothelin in Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
BQ-123
Intervention Type
Drug
Intervention Name(s)
BQ-123
Intervention Description
6-120 µg/min
Primary Outcome Measure Information:
Title
Pulmonary Vascular Resistance (PVR)
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.
Time Frame
Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Secondary Outcome Measure Information:
Title
Systemic Vascular Resistance (SVR)
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.
Time Frame
Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Title
Mean Pulmonary Artery Pressure (PAP)
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.
Time Frame
Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Title
Cardiac Output (CO)
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.
Time Frame
Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers or known diagnosis of pulmonary hypertension
Exclusion Criteria:
hypertension due to other reasons (not pulmonary)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Creager, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Role of Endothelin in Pulmonary Hypertension
We'll reach out to this number within 24 hrs