INTERVENCION Trial (INTERVENCION)

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

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 Overview

• Status: Unknown
• Conditions: Blood Pressure, High
• Intervention / Treatment: Drug: Hydrochlorothiazide; Drug: Amlodipine; Drug: Telmisartan

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Josefina E Medina-Lezama, MD; Phone Number: +5154251269; Email: Josefina Medina <jmedinal2911@gmail.com>

Study Locations

• Peru
  • AQP
    • Arequipa, AQP, Peru
      • Recruiting
      • Centro de Investigacion PREVENCION
      • Contact: Josefina E Medina-Lezama, MD; Phone Number: +5154251269; Email: Josefina Medina <jmedinal2911@gmail.com>

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diuretic; Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM	Drug: Hydrochlorothiazide; 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
Active Comparator: Calcium-channel blocker; Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM	Drug: Amlodipine; Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Active Comparator: Angiotensin Receptor Blocker; Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM	Drug: Telmisartan; Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change is 24-hour Systolic blood pressure from baseline to 4 weeks	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with controlled BP at 4 weeks	4 weeks
Change in 24-hour Diastolic blood pressure from baseline to 4 weeks	4 weeks
Change in 24-hour Mean arterial pressure from baseline to 4 weeks	4 weeks
Change in 24 hour Pulse pressure from baseline to 4 weeks	4 weeks
Change in Central (aortic) pulse pressure from baseline to 4 weeks	4 weeks
Change in Carotid-femoral pulse wave velocity from baseline to 4 weeks	4 weeks
Change in the magnitude of Wave reflections from baseline to 4 weeks	4 weeks

Collaborators and Investigators

• Sponsor: Prevencion

Publications and helpful links

General Publications

• Medina-Lezama J, Zea-Diaz H, Morey-Vargas OL, Bolanos-Salazar JF, Postigo-Macdowall M, Paredes-Diaz S, Corrales-Medina F, Valdivia-Ascuna Z, Cuba-Bustinza C, Villalobos-Tapia P, Munoz-Atahualpa E, Chirinos-Pacheco J, Raij L, Chirinos JA. Prevalence and patterns of hypertension in Peruvian Andean Hispanics: the PREVENCION study. J Am Soc Hypertens. 2007 May-Jun;1(3):216-25. doi: 10.1016/j.jash.2007.02.003.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Amlodipine; Hydrochlorothiazide; Telmisartan
• Other Study ID Numbers: INTERVENCION Trial