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: 9.1 Level: SOC Classification code 10007541 Term: Cardiac disorders
Conditions
Interventions
Product Name: Telmisartan
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Telmisartan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical for
Sponsors
ISTITUTO AUXOLOGICO ITALIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Exclusion criteria: ? 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to study the effect of telmisartan on the cardiovascular, respiratory, neural and metabolic responses to high altitude hypobaric hypoxia;Secondary Objective: - to investigate the cardiovascular, neural, endocrine, metabolic, hematologic and molecular effects of hypobaric hypoxia at extreme altitude at various stages of adaptation - to evaluate the acute physiological effects of nonpharmacological interventions potentially useful for the treatment of acute mountain sickness, including continuous positive airway pressure (CPAP) and controlled slow breathing (SlowB) to explore the relationship between changes in biological parameters and changes in meteorological parameters such as temperature, humidity and UV radiation exposure. Aims of this subproject will also be to monitor/forecast weather and microclimatic variables near the ground at different altitude, and to predict the physical/physiological performance in those environments by the assessments of thermal balances during different physical activities.;Primary end point(s): changes in bloode pressure ,heart rate, respiratory rate, oxygen saturation and metabolic parameters | — |
Countries
Italy
Outcome results
None listed