Masked HypertensionMASTERNCT02804074
MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement
A study testing Optimization of antihypertensive treatment based on office BP and Optimization of antihypertensive treatment based on 24-hour ABPM in people with Masked Hypertension, run by Istituto Auxologico Italiano at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Masked Hypertension
- What is being tested?
- Optimization of antihypertensive treatment based on office BP and Optimization of antihypertensive treatment based on 24-hour ABPM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,240 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Not yet recruiting
Istituto Auxologico Italiano
Milan
Gianfranco Parati, MD, 390261911 ext. 2890, gianfranco.parati@unimib.it
Venezuela1 site, 1 recruiting
- Recruiting
Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ
Maracaibo
Egle Silva, MD
About this study
Official title: 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).
- Conditions
- Masked Hypertension
- Being tested
- Optimization of antihypertensive treatment based on office BP, Optimization of antihypertensive treatment based on 24-hour ABPM
- Medical subject headings
- Masked Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization of antihypertensive treatment based on office BPOther
Optimization of antihypertensive treatment based on office BP
Optimization of antihypertensive treatment based on 24-hour ABPMOther
Optimization of antihypertensive treatment based on 24-hour ABPM
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Management strategy of blood pressure based on office BP as a guide to treatment Receives: 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 Receives: Other: Optimization of antihypertensive treatment based on 24-hour ABPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in LVMI (co-primary endpoint)
Measured: 12 months
UAE (albumin/creatinine ratio, co-primary end-point)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start1 Oct 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Masked HypertensionStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Hypertension
- Responsible party
- Sponsor
- Investigators
- Gianfranco Parati, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804074
- Sponsor's protocol ID
- 09A503
- Acronym
- MASTER
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2016
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)
- ClinicalTrials.gov ID
- NCT02804074
- Acronym / sponsor ID
- MASTER / 09A503
- Conditions
- Masked Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,240 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- European Society of Hypertension
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Optimization of antihypertensive treatment based on office BPManagement strategy of blood pressure based on office BP as a guide to treatment |
| Group 2 | Experimental | Other: Optimization of antihypertensive treatment based on 24-hour ABPMManagement strategy of blood pressure based on 24-hour ABPM as a guide to treatment |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- eGFR ≥45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009)
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimization of antihypertensive treatment based on office BPOptimization of antihypertensive treatment based on office BP | Other | Group 1 |
| Optimization of antihypertensive treatment based on 24-hour ABPMOptimization of antihypertensive treatment based on 24-hour ABPM | Other | Group 2 |
Primary outcome
changes in LVMI (co-primary endpoint)
Time frame: 12 months
UAE (albumin/creatinine ratio, co-primary end-point)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 30573476Parati 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.
- Individual participant dataSharing planned: Undecided
Related trials for Masked Hypertension
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Enrolling by invitationObservational study
Real-World Validation of A Huawei Smartwatch for Hypertension Risk Screening in Malaysia
Hypertension, Vascular Disease Risk
Not yet recruitingObservational study
Real-World Validation of Huawei Wearable Technologies for Hypertension Risk Screening in Malaysia
Hypertension
RecruitingPhase 1/2
A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage
Glaucoma
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gianfranco Parati, MD principal investigator
Istituto Auxologico Italiano
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimization of antihypertensive treatment based on office BP and Optimization of antihypertensive treatment based on 24-hour ABPM in people with Masked Hypertension, run by Istituto Auxologico Italiano at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianfranco Parati, MD (+390261911 ext. 2890, gianfranco.parati@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in LVMI (co-primary endpoint) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.