ClinicalTrials.gg
RecruitingNCT02804074MASTERUpdated Mar 30, 2026

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

An interventional study of Optimization of antihypertensive treatment based on office BP and Optimization of antihypertensive treatment based on 24-hour ABPM in Masked Hypertension, sponsored by Istituto Auxologico Italiano. Recruiting at 2 sites in 2 countries. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2018; still recruiting 8 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,240
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Masked Hypertension
03

In context

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • ≥45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009)

Exclusion criteria

Exclusion Criteria:

  • \<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 or ALT values > 2 times the
  • History of gastrointestinal surgery or disorders which could interfere with drug absorption
  • Known allergy or to one of the drugs to be administered in the study
  • History of including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years
  • History of 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
  • Pregnancy or planned pregnancy during study period.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,240 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherOptimization of antihypertensive treatment based on office BP

    Optimization of antihypertensive treatment based on office BP

  • OtherOptimization of antihypertensive treatment based on 24-hour ABPM

    Optimization of antihypertensive treatment based on 24-hour ABPM

06

What researchers measure

Primary outcomes

  1. changes in LVMI (co-primary endpoint)

    Time frame: 12 months

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

    Time frame: 12 months

07

Study locations

1 of 2 sites recruiting
  • Istituto Auxologico Italiano
    Milan, Italy
    Not yet recruiting
  • Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ
    Maracaibo, Venezuela
    Recruiting
    • Egle Silva, MD · Contact
08

References and documents

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. PubMed 30573476 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02804074
Collaborators
European Society of Hypertension
Responsible party
Sponsor
First posted
Jun 17, 2016
Start date
Oct 1, 2018
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 30, 2026

Study contacts

Gianfranco Parati, MD
Contact
gianfranco.parati@unimib.it
+390261911 ext. 2890
Alberto Zanchetti, MD
Contact
alberto.zanchetti@auxologico.it
+390261911 ext. 2901
Gianfranco Parati, MD
principal investigator · Istituto Auxologico Italiano

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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