Trial Outcomes & Findings for Effects of Nebivolol Versus Carvedilol on Cardiopulmonary Function at High Altitude in Healthy Subjects. (NCT NCT00924833)
NCT ID: NCT00924833
Last Updated: 2009-09-02
Results Overview
Oxygen consumption at peak of exercise
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.
Results posted on
2009-09-02
Participant Flow
Participants were recruited period between May 2006 and June 2006 at the Cardiology Division, S. Luca Hospital, Istituto Auxologico Italiano, Milan. Italy.
35 subjects were screened. Out of theese 7 subjects were excluded because they did not meet the inclusion/exclusion criteria. 27 subjects were randomized to the three treatment groups.
Participant milestones
| Measure |
Placebo
Placebo tablets. One tablet twice daily.
|
Carvedilol
Carvedilol 25 mg tablets. One tablet twice daily.
|
Nebivolol
Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Nebivolol Versus Carvedilol on Cardiopulmonary Function at High Altitude in Healthy Subjects.
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Placebo tablets. One tablet twice daily.
|
Carvedilol
n=9 Participants
Carvedilol 25 mg tablets. One tablet twice daily.
|
Nebivolol
n=9 Participants
Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
|
Total
n=27 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
44.1 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
39.22 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
32.7 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.Oxygen consumption at peak of exercise
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo tablets. One tablet twice daily.
|
Carvedilol
n=8 Participants
Carvedilol 25 mg tablets. One tablet twice daily.
|
Nebivolol
n=8 Participants
Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
|
|---|---|---|---|
|
Peak Exercise Oxygen Consumption
Time 1
|
33.9 ml/Kg/min
Standard Deviation 10.4
|
37.6 ml/Kg/min
Standard Deviation 4.3
|
38.0 ml/Kg/min
Standard Deviation 8.7
|
|
Peak Exercise Oxygen Consumption
Time 2
|
33.9 ml/Kg/min
Standard Deviation 9.4
|
36.2 ml/Kg/min
Standard Deviation 3.9
|
39.7 ml/Kg/min
Standard Deviation 8.6
|
|
Peak Exercise Oxygen Consumption
Time 3
|
22.9 ml/Kg/min
Standard Deviation 8.7
|
24.0 ml/Kg/min
Standard Deviation 4.1
|
28.8 ml/Kg/min
Standard Deviation 5.1
|
PRIMARY outcome
Timeframe: Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.Difference in peak exercise oxygen consumption between Time 1 and Time 3 (Time 3 - Time 1)
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo tablets. One tablet twice daily.
|
Carvedilol
n=9 Participants
Carvedilol 25 mg tablets. One tablet twice daily.
|
Nebivolol
n=9 Participants
Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
|
|---|---|---|---|
|
Delta Peak Exercise Oxygen Consumption Time 1 Versus Time 3
|
-32.7 ml/Kg/min
Standard Deviation 11
|
-37.6 ml/Kg/min
Standard Deviation 8.2
|
-22.5 ml/Kg/min
Standard Deviation 8
|
PRIMARY outcome
Timeframe: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.Minute ventilation at peak of exercise. Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo tablets. One tablet twice daily.
|
Carvedilol
n=8 Participants
Carvedilol 25 mg tablets. One tablet twice daily.
|
Nebivolol
n=8 Participants
Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
|
|---|---|---|---|
|
Peak Exercise Minute Ventilation
Time 1
|
93.9 L/min
Standard Deviation 29.1
|
90.3 L/min
Standard Deviation 21.8
|
81.8 L/min
Standard Deviation 24.4
|
|
Peak Exercise Minute Ventilation
Time 2
|
95.6 L/min
Standard Deviation 29.9
|
89.6 L/min
Standard Deviation 22.2
|
83.8 L/min
Standard Deviation 25.2
|
|
Peak Exercise Minute Ventilation
Time 3
|
90.3 L/min
Standard Deviation 19.9
|
84.5 L/min
Standard Deviation 27.4
|
92.0 L/min
Standard Deviation 20.7
|
PRIMARY outcome
Timeframe: Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.Difference in peak exercise minute ventilation between Time 1 and Time 3 (Time 3 - Time 1. Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min).
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo tablets. One tablet twice daily.
|
Carvedilol
n=8 Participants
Carvedilol 25 mg tablets. One tablet twice daily.
|
Nebivolol
n=8 Participants
Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
|
|---|---|---|---|
|
Delta Peak Exercise Minute Ventilation Time 1 Versus Time 3.
|
0.7 L/min
Standard Deviation 20.2
|
-9.3 L/min
Standard Deviation 13.3
|
15.2 L/min
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.Oxygen saturation by pulse oxymetry at peak of exercise
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.Outcome measures
Outcome data not reported
Adverse Events
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