INTERVENCION Trial

Prevencion

Status and phase: Completed; Phase 4

Conditions: Blood Pressure, High

Treatments: Drug: Amlodipine; Drug: Telmisartan; Drug: Hydrochlorothiazide

Study type: Interventional

Funder types: Other

Identifiers

NCT02373163

INTERVENCION Trial

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 3 patient groups

Diuretic

Active Comparator group

Description:

Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM

Treatment:

Drug: Hydrochlorothiazide

Calcium-channel blocker

Active Comparator group

Description:

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

Treatment:

Drug: Amlodipine

Angiotensin Receptor Blocker

Active Comparator group

Description:

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

Treatment:

Drug: Telmisartan