INTERVENCION Trial

Phase 4

• Conditions: Blood Pressure, High
• Interventions: Drug: Hydrochlorothiazide; Drug: Amlodipine; Drug: Telmisartan

• Registration Number: NCT02373163
• Lead Sponsor: Prevencion

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-21
• Primary Completion: 2016-03
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diuretic	Hydrochlorothiazide	Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Calcium-channel blocker	Amlodipine	Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Angiotensin Receptor Blocker	Telmisartan	Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 Central (aortic) pulse 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 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

Trial Locations

Locations (1)

Centro de Investigacion PREVENCION; 🇵🇪 Arequipa, AQP, Peru