Effects of Nebivolol Versus Carvedilol on Cardiopulmonary Function at High Altitude in Healthy Subjects.

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Istituto Auxologico Italiano
• Collaborator: Menarini Group
• Treatments: Carvedilol; Nebivolol

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