Trial Outcomes & Findings for Contribution of Endothelin-1 to Exercise Intolerance in Heart Failure (NCT NCT02124824)
NCT ID: NCT02124824
Last Updated: 2021-12-20
Results Overview
Ultrasound Doppler
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
30 participants
Primary outcome timeframe
two years
Results posted on
2021-12-20
Participant Flow
Participant milestones
| Measure |
Arm 1: Control
Control
BQ-123: Endothelin subtype A antagonist
|
Arm 2: Heart Failure
Heart Failure
BQ-123: Endothelin subtype A antagonist
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contribution of Endothelin-1 to Exercise Intolerance in Heart Failure
Baseline characteristics by cohort
| Measure |
Arm 1: Control
n=15 Participants
Control
BQ-123: Endothelin subtype A antagonist
|
Arm 2: Heart Failure
n=15 Participants
Heart Failure
BQ-123: Endothelin subtype A antagonist
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 4 • n=5 Participants
|
59 years
STANDARD_DEVIATION 6 • n=7 Participants
|
62 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: two yearsUltrasound Doppler
Outcome measures
| Measure |
Arm 1: Control
n=15 Participants
Control
BQ-123: Endothelin subtype A antagonist
|
Arm 2: Heart Failure
n=15 Participants
Heart Failure
BQ-123: Endothelin subtype A antagonist
|
|---|---|---|
|
Blood Flow
|
300 ml/min
Standard Error 50
|
275 ml/min
Standard Error 45
|
Adverse Events
Arm 1: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Heart Failure
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place