RecruitingNot ApplicableNCT02804074

MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement

MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)


Sponsor

Istituto Auxologico Italiano

Enrollment

1,240 participants

Start Date

Oct 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

MASTER study is a 4-year prospective, randomized, open-label, blinded-endpoint study (PROBE) comparing 2 management strategies 1) office BP as a guide to treatment, or 2) 24-hour ABP as a guide to treatment. Study objectives are to investigate whether a management strategy based on out-of-office BP (Ambulatory BP monitoring) versus a management strategy based on office BP measurements is associated with differences in outcome, including cardiovascular and renal intermediate end points at one year; cardiovascular events at 4 years and changes in a number of blood pressure-related variables throughout the study. Patients will be followed-up during the first year focusing on changes in left ventricular mass index (LVMI, co-primary endpoint) and Urinary albumin excretion (UAE, albumin/creatinine ratio, co-primary end-point), and during the whole 48 month period for both changes in LVMI and UAE and events including all-cause mortality, CV morbidity and mortality, cerebral morbidity and mortality.A total of 1240 subjects will be recruited by 30 centers, taking into account a dropout rate of 15% (620 subjects per randomization arm).


Eligibility

Min Age: 35 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at people whose blood pressure appears normal at the doctor's office but is actually too high when measured throughout the day — a condition called "masked" high blood pressure — to find the best way to monitor and manage it. **You may be eligible if...** - You are between 35 and 80 years old - Your blood pressure reading at the doctor's office is below 140/90, but your all-day wearable blood pressure monitor shows readings that are too high - You are currently taking blood pressure medication - Your kidneys are working at least at a moderate level (your doctor can check this with a blood test) **You may NOT be eligible if...** - Your kidneys are severely damaged - You are in an unstable health condition - Your high blood pressure has a known specific cause such as a hormone problem - You have low blood pressure when you stand up - You have dementia - You have significant liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROptimization of antihypertensive treatment based on office BP

Optimization of antihypertensive treatment based on office BP

OTHEROptimization of antihypertensive treatment based on 24-hour ABPM

Optimization of antihypertensive treatment based on 24-hour ABPM


Locations(2)

Istituto Auxologico Italiano

Milan, Italy

Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ

Maracaibo, Venezuela

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NCT02804074