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INTERVENCION Trial (INTERVENCION)

Primary Purpose

Blood Pressure, High

Status

Unknown status

Phase

Phase 4

Locations

Peru

Study Type

Interventional

Intervention

Hydrochlorothiazide

Amlodipine

Telmisartan

About this trial

This is an interventional treatment trial for Blood Pressure, High

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centro de Investigacion PREVENCIONRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Diuretic

Calcium-channel blocker

Angiotensin Receptor Blocker

Arm Description

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

Outcomes

Primary Outcome Measures

Change is 24-hour Systolic blood pressure from baseline to 4 weeks

Secondary Outcome Measures

Proportion of participants with controlled BP at 4 weeks

Change in 24-hour Diastolic blood pressure from baseline to 4 weeks

Change in 24-hour Mean arterial pressure from baseline to 4 weeks

Change in 24 hour Pulse pressure from baseline to 4 weeks

Change in Central (aortic) pulse pressure from baseline to 4 weeks

Change in Carotid-femoral pulse wave velocity from baseline to 4 weeks

Change in the magnitude of Wave reflections from baseline to 4 weeks

Full Information

NCT ID

NCT02373163

First Posted

February 10, 2015

Last Updated

October 19, 2015

Sponsor

Prevencion

1. Study Identification

Unique Protocol Identification Number

NCT02373163

Brief Title

INTERVENCION Trial

Acronym

INTERVENCION

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prevencion

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Pressure, High

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diuretic

Arm Type

Active Comparator

Arm Description

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

Arm Title

Calcium-channel blocker

Arm Type

Active Comparator

Arm Description

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

Arm Title

Angiotensin Receptor Blocker

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hydrochlorothiazide

Other Intervention Name(s)

HCTZ

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Amlodipine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Telmisartan

Intervention Description

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

Primary Outcome Measure Information:

Title

Change is 24-hour Systolic blood pressure from baseline to 4 weeks

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Proportion of participants with controlled BP at 4 weeks

Time Frame

4 weeks

Title

Change in 24-hour Diastolic blood pressure from baseline to 4 weeks

Time Frame

4 weeks

Title

Change in 24-hour Mean arterial pressure from baseline to 4 weeks

Time Frame

4 weeks

Title

Change in 24 hour Pulse pressure from baseline to 4 weeks

Time Frame

4 weeks

Title

Change in Central (aortic) pulse pressure from baseline to 4 weeks

Time Frame

4 weeks

Title

Change in Carotid-femoral pulse wave velocity from baseline to 4 weeks

Time Frame

4 weeks

Title

Change in the magnitude of Wave reflections from baseline to 4 weeks

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Josefina E Medina-Lezama, MD

Phone

+5154251269

Josefina Medina <jmedinal2911@gmail.com>

Facility Information:

Facility Name

Centro de Investigacion PREVENCION

City

Arequipa

State/Province

AQP

Country

Peru

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Josefina E Medina-Lezama, MD

Phone

+5154251269

Josefina Medina <jmedinal2911@gmail.com>

12. IPD Sharing Statement

Citations:

PubMed Identifier

20409853

Citation

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.

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