Role of the renin-angiotensin system in the cardiovascular, metabolic, neurologic and respiratory response to hypobaric hypoxia during sustained exposure to high altitude. - HIGHCARE
- Conditions
- This study is aimed at the investigation of adaptative physiological mechanisms at high altitude and not at the development of new therapeutic indications.MedDRA version: 9.1Level: SOCClassification code 10007541Term: Cardiac disorders
- Registration Number
- EUCTR2008-000540-14-IT
- Lead Sponsor
- ISTITUTO AUXOLOGICO ITALIANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Group A: ? male and female volunteers aged 20 to 65 years with high altitude climbing expertise (including professional climbers) ? informed consent to study procedures Group E ? male and female volunteers residing at low altitude aged 20 to 65 years ? informed consent to study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
? chronic therapy with cardiovascular drugs, beta-mimetics and other drugs that may interfere with the physiological mechanisms under study or may be unsafe in high altitude conditions ? pregnancy ? repeated exposures to altitudes >3000 m a.s.l. in the 8 months preceding the expedition ? history of severe AMS forms including HAPE and HACE ? relevant chronic diseases (any chronic cardiovascular or renal disease, diseases that reduce functional capacity, infectious diseases) ? relevant diseases in the past (pneumothorax, major thoracic traumas, major surgical procedures etc.)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method