INTERVENCION Trial

Prevencion166 enrolled

Overview

This trial is designed to: 1. 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. 2. To test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level 3. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

166

Conditions

Blood Pressure, High

Interventions

HydrochlorothiazideDRUG

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

AmlodipineDRUG

Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM

TelmisartanDRUG

Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 45-75 years. Enrollment will be stratified by age group (50-65 and 66-80 years), gender and altitude above sea level 2. Leaving in the enrollment cities for at least 2 years 3. Untreated hypertension for at least 2 weeks 4. Systolic BP between 140 and 160 mmHg and/or diastolic BP between 90 and 99 mmHg, in the absence of therapy. Exclusion Criteria: 1. Diabetes mellitus. 2. Chronic kidney disease (estimated glomerular filtration rate \<60 ml / minute / 1.73 m2 of body surface area. 3. Smoking. 4. Lung disease, liver disease or active cancer 5. Any factor that, in the opinion of the investigator, decreases short-term survival 6. Psychiatric illness 7. Inability to provide informed consent 8. Established heart disease (previous myocardial infarction, heart failure, valvular heart disease, cardiomyopathy, atrial fibrillation or any significant cardiac arrhythmia) 9. History of cerebrovascular disease 10. History of orthostatic hypotension. 11. History of syncope. 12. History of allergy of adverse effects to study medications or drugs of the same pharmacologic classes.

Locations (1)

Centro de Investigacion PREVENCION

Arequipa, AQP, Peru

Outcomes

Primary Outcomes

Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks

Time frame: 4 weeks

Secondary Outcomes

Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks

Time frame: 4 weeks

Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks

Time frame: 4 weeks

Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks

Time frame: 4 weeks

Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks

Time frame: 4 weeks

Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks

Time frame: 4 weeks

Data from ClinicalTrials.gov

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