The Role of Endothelin in Pulmonary Hypertension

November 1, 2018 updated by: Anju Nohria, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers or known diagnosis of pulmonary hypertension

Exclusion Criteria:

  • hypertension due to other reasons (not pulmonary)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
BQ-123
Drug: BQ-123
6-120 µg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Vascular Resistance (PVR)
Time Frame: 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.
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)
Time Frame: 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.
Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Mean Pulmonary Artery Pressure (PAP)
Time Frame: 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.
Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Cardiac Output (CO)
Time Frame: 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.
Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1999-P-003126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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