Phase 4
N=27
Effects of Nebivolol Versus Carvedilol on Cardiopulmonary Function at High Altitude in Healthy Subjects.
Hypoxia · Altitude · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00924833 ↗Enrolled (actual)
27
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Peak Exercise Oxygen Consumption — 33.9; 37.6; 38.0; 33.9 ml/Kg/min — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- placebo (Drug); Carvedilol (Drug); Nebivolol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Istituto Auxologico Italiano
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Exercise Oxygen Consumption |
33.9; 37.6; 38.0; 33.9; 36.2; 39.7 | 0.01 sig |
| PRIMARY Delta Peak Exercise Oxygen Consumption Time 1 Versus Time 3 |
-32.7; -37.6; -22.5 | <0.05 sig |
| PRIMARY Peak Exercise Minute Ventilation |
93.9; 90.3; 81.8; 95.6; 89.6; 83.8 | 0.93 |
| PRIMARY Delta Peak Exercise Minute Ventilation Time 1 Versus Time 3. |
0.7; -9.3; 15.2 | <0.05 sig |
| SECONDARY Peak Exercise Oxygen Saturation |
— | — |
| SECONDARY Systolic Pulmonary Artery Pressure. |
— | — |
| SECONDARY Resting Energy Expenditure |
— | — |
| SECONDARY Sitting Blood Pressure and Heart Rate |
— | — |
| SECONDARY Mean 24 Hour/Daytime/Night-time Blood Pressure and Heart Rate |
— | — |
Summary
Exposure of healthy subjects to high altitude hypoxia elicits changes in cardiovascular, respiratory and metabolic features as weel as in exercise performance similar, for some aspects, to those observed in chronic heart failure. Exposure to high altitude hypoxia represents a suitable model to assess different treatments proposed for this pathological condition. Our aim was to evaluate the impact of two different third-generation beta-blockers used in heart failure (carvedilol and nebivolol) on cardiovascular, respiratory, metabolic profile and on exercise performance at high altitude.
Eligibility Criteria
Inclusion Criteria
- Men or women of any racial background
- healthy
- sealevel resident
- age >= 18 years, =< 65 years
- SBP< 130 mmHg and DBP< 80 mmHg, average of two measures at the sceening visit
- FG < 100 mg/dl (5.6 mmol/l)
- BMI < 25
- written informed consent signed
Exclusion Criteria
- engagement in regular exercise training
- smoking habit
- being enrolled in another research study
- any current or previous cardiovascular, metabolic disease or any other cronic disease
- any current treatment for any medical condition
- any medical condition preventing or contraindication exposure to altitude hypoxia
- any gastrointestinal disorder interfering with drug absorption
- known allergy or contraindications to beta-blockers
- pregnant or lactating women; women in reproductive age not using recognized contraceptive methods.
- malignancy within the last 5 years
- drug abuse or alcohol abuse within the last 5 years
- history of noncompliance to medical regimens
- incapacity or unwillingness to sign the informed consent
- participation in any investigational clinical trial within the last 3 months
Data sourced from ClinicalTrials.gov (NCT00924833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.