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

NCT02804074 | Recruiting DMC

• 1 other identifier: 09A503
• Study Type: interventional
• Target: 1,240
• Locations: 2 countries
• Sites: 2

Brief 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).

Conditions

Masked Hypertension

Outcome Measures

Primary Outcomes (2)

• changes in LVMI (co-primary endpoint)

  12 months

• UAE (albumin/creatinine ratio, co-primary end-point)

  12 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Management strategy of blood pressure based on office BP as a guide to treatment

Other: Optimization of antihypertensive treatment based on office BP

Group 2

EXPERIMENTAL

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

Interventions

Optimization of antihypertensive treatment based on office BP OTHER

Optimization of antihypertensive treatment based on office BP

Group 1

Optimization of antihypertensive treatment based on 24-hour ABPM OTHER

Optimization of antihypertensive treatment based on 24-hour ABPM

Group 2

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• European Society of Hypertension: collaborator

Study Sites (2)

Istituto Auxologico Italiano

Milan, Italy

NOT YET RECRUITING

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

Maracaibo, Venezuela

RECRUITING

Related Publications (1)

• 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.

  PMID: 30573476 DERIVED

MeSH Terms

Conditions

Masked Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gianfranco Parati, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianfranco Parati, MD

CONTACT

+390261911; gianfranco.parati@unimib.it

Alberto Zanchetti, MD

CONTACT

+390261911; alberto.zanchetti@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: October 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

VE (1); IT (1)