NCT02804074Recruiting
MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement
MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1240 (estimated)
- First submitted
- 14 Jun 2016
- Start date
- 1 Oct 2018
- Primary completion date
- Dec 2026
- Lead sponsor
- Istituto Auxologico Italiano
- Diseases
- High blood pressure
- NCT number
- NCT02804074
What you commit to
- Study type: Interventional
- Planned participants: 1240
- From 1 Oct 2018 to the primary completion date, Dec 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients in unstable clinical conditions;
- Known secondary hypertension;
- Dementia (clinical diagnosis);
- 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
Lab values
- 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;
- Hepatic disease as determined by either AST or ALT values \> 2 times the upper limit of normal
Other
- Orthostatic hypotension (SBP fall \> 20 mmHg on standing);
- Inability or unwillingness to give free informed consent
- Pregnancy or planned pregnancy during study period.
Who the study is looking for
- 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)
Age in the registry: 35 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Auxologico Italiano Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ Coordinator of this site? Confirm its status | Maracaibo | Venezuela | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.