Clinical trial NCT02373163: INTERVENCION Trial
Official title: Characterization of Arterial Hypertension and Efficacy of Blood-pressure Lowering Therapy at Different Altitudes Above Sea Level
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Blood Pressure, High
Lead sponsor: Prevencion
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change is 24-hour Systolic blood pressure from baseline to 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of participants with controlled BP at 4 weeks
timeFrame: 4 weeks
measure: Change in 24-hour Diastolic blood pressure from baseline to 4 weeks
timeFrame: 4 weeks
measure: Change in 24-hour Mean arterial pressure from baseline to 4 weeks
timeFrame: 4 weeks
measure: Change in 24 hour Pulse pressure from baseline to 4 weeks
timeFrame: 4 weeks
measure: Change in Central (aortic) pulse pressure from baseline to 4 weeks
timeFrame: 4 weeks
measure: Change in Carotid-femoral pulse wave velocity from baseline to 4 weeks
timeFrame: 4 weeks
measure: Change in the magnitude of Wave reflections from baseline to 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Arequipa
country: Peru
facility: Centro de Investigacion PREVENCION
state: AQP
Study officials:
References:
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.