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Completed

NCT Number: NCT02373163

INTERVENCION Trial

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.

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Key information

Conditions

Blood Pressure, High Cardiovascular Diseases Hypertension Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro de Investigacion PREVENCION

Arequipa, AQP, Peru

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrochlorothiazide

Drug

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

Other names: HCTZ

Amlodipine

Drug

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

Telmisartan

Drug

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

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

  3. Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks

    Time frame: 4 weeks

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Prevencion

Other

Registry information

Official study title

Characterization of Arterial Hypertension and Efficacy of Blood-pressure Lowering Therapy at Different Altitudes Above Sea Level

Acronym: INTERVENCION

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2015
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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