Trial Outcomes & Findings for The Role of Endothelin in Pulmonary Hypertension (NCT NCT00759408)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

Results posted on

2018-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	BQ-123 BQ-123 (6-120 µg/min) will be administered intravenously.
Overall Study STARTED	38
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Endothelin in Pulmonary Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BQ-123 n=38 Participants BQ-123 (6-120 µg/min) will be administered intravenously.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

Population: Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.

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.

Outcome measures

Outcome measures
Measure	BQ-123 n=19 Participants BQ-123 (6-120 µg/min) will be administered intravenously.
Pulmonary Vascular Resistance (PVR) Baseline	64 dyn*sec/cm^5 Standard Error 5
Pulmonary Vascular Resistance (PVR) Time 2: Hypoxia	119 dyn*sec/cm^5 Standard Error 10
Pulmonary Vascular Resistance (PVR) Time 3: Normoxia	67 dyn*sec/cm^5 Standard Error 5
Pulmonary Vascular Resistance (PVR) Time 4: Normoxia/BQ-123	46 dyn*sec/cm^5 Standard Error 5
Pulmonary Vascular Resistance (PVR) Time 5: Hypoxia/BQ-123	85 dyn*sec/cm^5 Standard Error 9

SECONDARY outcome

Timeframe: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

Population: Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.

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.

Outcome measures

Outcome measures
Measure	BQ-123 n=19 Participants BQ-123 (6-120 µg/min) will be administered intravenously.
Systemic Vascular Resistance (SVR) Baseline	1368 dyn*sec/cm^5 Standard Error 52
Systemic Vascular Resistance (SVR) Time 2: Hypoxia	1050 dyn*sec/cm^5 Standard Error 57
Systemic Vascular Resistance (SVR) Time 3: Normoxia	1351 dyn*sec/cm^5 Standard Error 44
Systemic Vascular Resistance (SVR) Time 4: Normoxia/BQ-123	1069 dyn*sec/cm^5 Standard Error 38
Systemic Vascular Resistance (SVR) Time 5: Hypoxia/BQ-123	828 dyn*sec/cm^5 Standard Error 43

SECONDARY outcome

Timeframe: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

Population: Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.

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.

Outcome measures

Outcome measures
Measure	BQ-123 n=19 Participants BQ-123 (6-120 µg/min) will be administered intravenously.
Mean Pulmonary Artery Pressure (PAP) Baseline	10 mmHg Standard Error 1
Mean Pulmonary Artery Pressure (PAP) Time 2: Hypoxia	15 mmHg Standard Error 1
Mean Pulmonary Artery Pressure (PAP) Time 3: Normoxia	10 mmHg Standard Error 1
Mean Pulmonary Artery Pressure (PAP) Time 4: Normoxia/BQ-123	9 mmHg Standard Error 1
Mean Pulmonary Artery Pressure (PAP) Time 5: Hypoxia/BQ-123	14 mmHg Standard Error 1

SECONDARY outcome

Timeframe: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)

Population: Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.

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.

Outcome measures

Outcome measures
Measure	BQ-123 n=19 Participants BQ-123 (6-120 µg/min) will be administered intravenously.
Cardiac Output (CO) Baseline	5.3 l/min Standard Error 0.3
Cardiac Output (CO) Time 2: Hypoxia	6.7 l/min Standard Error 0.4
Cardiac Output (CO) Time 3: Normoxia	5.2 l/min Standard Error 0.3
Cardiac Output (CO) Time 4: Normoxia/BQ-123	6.4 l/min Standard Error 0.3
Cardiac Output (CO) Time 5: Hypoxia/BQ-123	8.3 l/min Standard Error 0.6

Adverse Events

BQ-123

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anju Nohria, MD

Brigham and Women's Hospital

Phone: 617-525-6852

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place