INTERVENCION Trial

Blood Pressure, High Clinical Trial

— INTERVENCION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02373163
• Other study ID #: INTERVENCION Trial
• Status: Recruiting
• Phase: Phase 4
• First received: February 10, 2015
• Last updated: October 19, 2015
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Prevencion
• Contact: Josefina E Medina-Lezama, MD
• Phone: +5154251269
• Email: Josefina Medina [@]gmail.com>
• Is FDA regulated: No
• Health authority: Peru: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure, High
• Hypertension

Intervention

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
• Amlodipine
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
• Telmisartan
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM

Locations

Country	Name	City	State
Peru	Centro de Investigacion PREVENCION	Arequipa	AQP

Sponsors (1)

Lead Sponsor	Collaborator
Prevencion

Country where clinical trial is conducted

Peru, 

References & Publications (1)

Medina-Lezama J, Zea-Diaz H, Morey-Vargas OL, Bolaños-Salazar JF, Postigo-Macdowall M, Paredes-Díaz S, Corrales-Medina F, Valdivia-Ascuña Z, Cuba-Bustinza C, Villalobos-Tapia P, Muñoz-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change is 24-hour Systolic blood pressure from baseline to 4 weeks		4 weeks	No
Secondary	Proportion of participants with controlled BP at 4 weeks		4 weeks	No
Secondary	Change in 24-hour Diastolic blood pressure from baseline to 4 weeks		4 weeks	No
Secondary	Change in 24-hour Mean arterial pressure from baseline to 4 weeks		4 weeks	No
Secondary	Change in 24 hour Pulse pressure from baseline to 4 weeks		4 weeks	No
Secondary	Change in Central (aortic) pulse pressure from baseline to 4 weeks		4 weeks	No
Secondary	Change in Carotid-femoral pulse wave velocity from baseline to 4 weeks		4 weeks	No
Secondary	Change in the magnitude of Wave reflections from baseline to 4 weeks		4 weeks	No