Actively Recruiting
MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement
Led by Istituto Auxologico Italiano · Updated on 2026-03-30
1240
Participants Needed
2
Research Sites
426 weeks
Total Duration
On this page
Sponsors
I
Istituto Auxologico Italiano
Lead Sponsor
E
European Society of Hypertension
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects
- Age 35-80 years
- Masked uncontrolled (in treatment) hypertension with office BP <140/90 mmHg and at least one of: ambulatory daytime BP >135/85 mmHg, ambulatory night-time BP >120/70 mmHg, or ambulatory 24h BP >130/80 mmHg
- Estimated glomerular filtration rate (eGFR) 65 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009)
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2, especially severe chronic renal failure with serum creatinine > 250 umol/l
- Unstable clinical conditions
- Known secondary hypertension
- Orthostatic hypotension with systolic BP drop >20 mmHg on standing
- Clinical diagnosis of dementia
- Hepatic disease with AST or ALT >2 times upper normal limit
- History of gastrointestinal surgery or disorders affecting drug absorption
- Known allergy or contraindications to study drugs
- History of malignancy (excluding basal cell skin cancer) within last 5 years
- Clinically significant autoimmune disorders like systemic lupus erythematosus
- History of drug or alcohol abuse within last 5 years
- History of non-compliance or considered potentially unreliable
- Inability or unwillingness to give informed consent
- Pregnancy or planned pregnancy during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Istituto Auxologico Italiano
Milan, Italy
Not Yet Recruiting
2
Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ
Maracaibo, Venezuela
Actively Recruiting
Research Team
G
Gianfranco Parati, MD
CONTACT
A
Alberto Zanchetti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here