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

NCT ID: NCT02804074

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

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

Group Type: ACTIVE_COMPARATOR

Optimization of antihypertensive treatment based on office BP

Intervention Type: OTHER

Optimization of antihypertensive treatment based on office BP

Group 2

Management strategy of blood pressure based on 24-hour ABPM as a guide to treatment

Group Type: EXPERIMENTAL

Optimization of antihypertensive treatment based on 24-hour ABPM

Intervention Type: OTHER

Optimization of antihypertensive treatment based on 24-hour ABPM

Interventions

Optimization of antihypertensive treatment based on office BP

Optimization of antihypertensive treatment based on office BP

Intervention Type: OTHER

Optimization of antihypertensive treatment based on 24-hour ABPM

Optimization of antihypertensive treatment based on 24-hour ABPM

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society of Hypertension

OTHER

Sponsor Role: collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianfranco Parati, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano

Locations

Istituto Auxologico Italiano

Milan, , Italy

Site Status: NOT_YET_RECRUITING

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

Maracaibo, , Venezuela

Site Status: RECRUITING

Countries

Italy; Venezuela

Central Contacts

Gianfranco Parati, MD

Role: CONTACT

gianfranco.parati@unimib.it

+390261911 ext. 2890

Alberto Zanchetti, MD

Role: CONTACT

alberto.zanchetti@auxologico.it

+390261911 ext. 2901

Facility Contacts

Gianfranco Parati, MD

Role: primary

gianfranco.parati@unimib.it

390261911 ext. 2890

Egle Silva, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 30573476 (View on PubMed)

Other Identifiers

09A503

Identifier Type: -

Identifier Source: org_study_id