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

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ClinicalTrials.gov Identifier: NCT02804074

Recruitment Status : Recruiting

First Posted : June 17, 2016

Last Update Posted : June 12, 2020

See Contacts and Locations

Sponsor:

Collaborator:

European Society of Hypertension

Information provided by (Responsible Party):

Istituto Auxologico Italiano

Tracking Information

First Submitted Date ^ICMJE

June 14, 2016

First Posted Date ^ICMJE

June 17, 2016

Last Update Posted Date

June 12, 2020

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Masked Hypertension

Intervention ^ICMJE

Other: Optimization of antihypertensive treatment based on office BP
Optimization of antihypertensive treatment based on office BP
Other: Optimization of antihypertensive treatment based on 24-hour ABPM
Optimization of antihypertensive treatment based on 24-hour ABPM

Study Arms ^ICMJE

Active Comparator: Group 1
Management strategy of blood pressure based on office BP as a guide to treatment

Intervention: Other: 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

Intervention: Other: Optimization of antihypertensive treatment based on 24-hour ABPM

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, Jelaković 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1240

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

January 2023

Estimated Primary Completion Date

December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

35 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Gianfranco Parati, MD	+390261911 ext 2890	gianfranco.parati@unimib.it
Contact: Alberto Zanchetti, MD	+390261911 ext 2901	alberto.zanchetti@auxologico.it

Listed Location Countries ^ICMJE

Italy, Venezuela

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02804074

Other Study ID Numbers ^ICMJE

09A503

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Undecided

Responsible Party

Istituto Auxologico Italiano

Study Sponsor ^ICMJE

Istituto Auxologico Italiano

Collaborators ^ICMJE

European Society of Hypertension

Investigators ^ICMJE

Principal Investigator:

Gianfranco Parati, MD

Istituto Auxologico Italiano

PRS Account

Istituto Auxologico Italiano

Verification Date

June 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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