Trial Outcomes & Findings for Endothelin Blockade in Patients With Single Ventricle Physiology (NCT NCT00989911)
NCT ID: NCT00989911
Last Updated: 2015-02-27
Results Overview
Magnetic resonance imaging-derived aortic flow
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
3-6 months
Results posted on
2015-02-27
Participant Flow
Participant milestones
| Measure |
Bosentan
Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endothelin Blockade in Patients With Single Ventricle Physiology
Baseline characteristics by cohort
| Measure |
Bosentan
n=10 Participants
Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-6 monthsMagnetic resonance imaging-derived aortic flow
Outcome measures
| Measure |
Bosentan
n=7 Participants
Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
|
|---|---|
|
Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months
BaselineAortic Flow Volume
|
3.3 L/min
Standard Deviation 1.27
|
|
Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months
3-6 Month Aortic Flow Volume
|
4.4 L/min
Standard Deviation 0.9
|
Adverse Events
Bosentan
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bosentan
n=10 participants at risk
Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
|
|---|---|
|
Cardiac disorders
fatigue
|
30.0%
3/10 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place