Title
INTERVENCION Trial
Characterization of Arterial Hypertension and Efficacy of Blood-pressure Lowering Therapy at Different Altitudes Above Sea Level
Phase
Phase 4Lead Sponsor
Santa Maria Catholic UniversityStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Blood Pressure, HighIntervention/Treatment
amlodipine hydrochlorothiazide telmisartan ...Study Participants
120This trial is designed to:
Assess the response to montherapy with : a thiazide diuretic (HCTZ), a calcium-channel blocker (CCB, amlodipine) and an angiotensin-receptor blocker (telmisartan), among hypertensive subjects who live at sea level, at medium altitude above sea level and at high altitude above sea level.
To test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level
To assess the hemodynamic characteristics of hypertension in populations that live at sea level, at medium altitude above sea level, and at high altitude above sea level.
Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Inclusion Criteria: Age 45-75 years. Enrollment will be stratified by age group (50-65 and 66-80 years), gender and altitude above sea level Leaving in the enrollment cities for at least 2 years Untreated hypertension for at least 2 weeks Systolic BP between 140 and 160 mmHg and/or diastolic BP between 90 and 99 mmHg, in the absence of therapy. Exclusion Criteria: Diabetes mellitus. Chronic kidney disease (estimated glomerular filtration rate <60 ml / minute / 1.73 m2 of body surface area. Smoking. Lung disease, liver disease or active cancer Any factor that, in the opinion of the investigator, decreases short-term survival Psychiatric illness Inability to provide informed consent Established heart disease (previous myocardial infarction, heart failure, valvular heart disease, cardiomyopathy, atrial fibrillation or any significant cardiac arrhythmia) History of cerebrovascular disease History of orthostatic hypotension. History of syncope. History of allergy of adverse effects to study medications or drugs of the same pharmacologic classes.
