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OpenTrials
Completed

NCT Number: NCT00759408

The Role of Endothelin in Pulmonary Hypertension

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Familial Primary Pulmonary Hypertension Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers or known diagnosis of pulmonary hypertension

Exclusion criteria

  • hypertension due to other reasons (not pulmonary)

Treatment and study plan

BQ-123

Drug

6-120 µg/min

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
1999
Primary completion
2010
Study completion
2011
First posted
Sep 25, 2008
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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