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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Masked Hypertension
• Intervention / Treatment: Other: Optimization of antihypertensive treatment based on office BP; Other: Optimization of antihypertensive treatment based on 24-hour ABPM

• Study Type: Interventional
• Enrollment (Estimated): 1240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gianfranco Parati, MD; Phone Number: 2890 +390261911; Email: gianfranco.parati@unimib.it
• Study Contact Backup: Name: Alberto Zanchetti, MD; Phone Number: 2901 +390261911; Email: alberto.zanchetti@auxologico.it

Study Locations

• Italy
  • Milan, Italy
    • Not yet recruiting
    • Istituto Auxologico Italiano
    • Contact: Gianfranco Parati, MD; Phone Number: 2890 390261911; Email: gianfranco.parati@unimib.it
• Venezuela
  • Maracaibo, Venezuela
    • Recruiting
    • Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ
    • Contact: Egle Silva, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female subjects
• Age 35-80 years

• Masked uncontrolled (in treatment) hypertension: office BP <140/90 mmHg, and one or more of the following situations:

  • Ambulatory daytime BP >135/85 mmHg
  • Ambulatory night-time ABP > 120/70 mmHg
  • Ambulatory 24h ABP >130/80 mmHg
• eGFR ≥45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009)

Exclusion Criteria:

• eGFR <45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009), and in particular severe chronic renal failure defined as serum creatinine > 250 umol/l;
• Patients in unstable clinical conditions;
• Known secondary hypertension;
• Orthostatic hypotension (SBP fall > 20 mmHg on standing);
• Dementia (clinical diagnosis);
• Hepatic disease as determined by either AST or ALT values > 2 times the upper limit of normal
• History of gastrointestinal surgery or disorders which could interfere with drug absorption
• Known allergy or contraindications to one of the drugs to be administered in the study
• History of malignancy including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years
• History of clinically significant autoimmune disorders such as systemic lupus erythematosus.
• History of drug or alcohol abuse within the last 5 years
• History of non-compliance to medical regimens and/or patients who are considered potentially unreliable
• Inability or unwillingness to give free informed consent
• Pregnancy or planned pregnancy during study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Management strategy of blood pressure based on office BP as a guide to treatment	Other: Optimization of antihypertensive treatment based on office BP; Optimization of antihypertensive treatment based on office BP
Experimental: Group 2; Management strategy of blood pressure based on 24-hour ABPM as a guide to treatment	Other: Optimization of antihypertensive treatment based on 24-hour ABPM; Optimization of antihypertensive treatment based on 24-hour ABPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in LVMI (co-primary endpoint)	12 months
UAE (albumin/creatinine ratio, co-primary end-point)	12 months

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: European Society of Hypertension
• Investigators: Principal Investigator: Gianfranco Parati, MD, Istituto Auxologico Italiano

Publications and helpful links

General Publications

• Parati G, Agabiti-Rosei E, Bakris GL, Bilo G, Branzi G, Cecchi F, Chrostowska M, De la Sierra A, Domenech M, Dorobantu M, Faria T, Huo Y, Jelakovic B, Kahan T, Konradi A, Laurent S, Li N, Madan K, Mancia G, McManus RJ, Modesti PA, Ochoa JE, Octavio JA, Omboni S, Palatini P, Park JB, Pellegrini D, Perl S, Podoleanu C, Pucci G, Redon J, Renna N, Rhee MY, Rodilla Sala E, Sanchez R, Schmieder R, Soranna D, Stergiou G, Stojanovic M, Tsioufis K, Valsecchi MG, Veglio F, Waisman GD, Wang JG, Wijnmaalen P, Zambon A, Zanchetti A, Zhang Y. MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study: a randomised controlled trial protocol. BMJ Open. 2018 Dec 19;8(12):e021038. doi: 10.1136/bmjopen-2017-021038.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimated): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Masked Hypertension; Antihypertensive Agents
• Other Study ID Numbers: 09A503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No