HIGH Altitude CArdiovascular REsearch in the ANDES
Condition: Hypertension; High Altitude
MeSH terms: Altitude Sickness; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is aimed to assess the efficacy of combined treatment with two antihypertensive
      agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high
      altitude.
    

Detailed description: 
      This is a parallel group, prospective, double-blind, placebo controlled randomized trial,
      comparing the effects of combination of two antihypertensive agents
      (telmisartan/nifedipine)with placebo in hypertensive subjects exposed to high altitude. The
      principal objectives are:

        1. to assess the response of BP to high altitude exposure in hypertensive subjects residing
           at sea level

        2. To assess the efficacy and safety of combination of telmisartan 80 mg with nifedipine
           GITS 30 mg in preventing a possible excessive BP increase in hypertensive subjects
           exposed to high altitude.

      The following data will be collected during the study at the different steps:

        -  Clinical history

        -  Symptoms and adverse events questionnaire

        -  Conventional BP and heart rate (HR) measurement - seated measurements with a validated
           oscillometric device will be performed after at least 5 minutes rest on non-dominant
           arm; two measurements will be performed 1-2 minutes apart and their average will be used
           in the analyses

        -  Vital signs:

      respiratory rate - will be measured manually over 60 seconds body height and weight, waist
      circumference blood oxygen saturation (SpO2)

        -  Lake Louise Score

        -  24 h ambulatory blood pressure monitoring (ABPM; AND TM2430, AND, Japan)

        -  Echocardiography

        -  Arterial properties assessment

        -  Six minute walking test (6MWT)

        -  Cardiopulmonary Exercise Test (CPET) in a subgroup of subjects

        -  Polysomnography with a portable device

        -  Pulmonary function tests (only at sea level baseline visit)

        -  Fluid balance chart

        -  Blood and urine analyses: Visit 1: electrolytes, creatinine, estimated glomerular
           filtration rate (eGFR), glycemia, renin, angiotensin, aldosterone, plasma
           catecholamines, 24 h urinary sodium excretion, carbonic anhydrase activity and isoenzyme
           expression (in 50 randomly selected subjects), samples for genetic studies. Visit 2:
           electrolytes, creatinine, eGFR. Visit 3: complete blood count, electrolytes, creatinine,
           eGFR, glycemia, insulin, renin, angiotensin, aldosterone, plasma catecholamines, classic
           urinalysis, microalbuminuria, 24 h urinary sodium excretion, carbonic anhydrase activity
           and isoenzyme expression (in 50 subjects selected at Visit 1). Visit 4: electrolytes,
           creatinine, eGFR, glycemia, insulin, renin, angiotensin, aldosterone, plasma
           catecholamines, 24 h urinary sodium excretion, carbonic anhydrase activity and isoenzyme
           expression (in 50 subjects selected at Visit 1)
    

Intervention name(s): Telmisartan; Nifedipine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination; Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination; two tablets daily in the morning
Other intervention name(s): Pritor; Micardis; Adalat
Intervention MeSH terms: Telmisartan; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arterial hypertension; high altitude; hypobaric hypoxia; combination treatment; angiotensin receptor blocker; calcium antagonist