Managing masked hypertension with different blood pressure measurement methods

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

This study is testing whether using 24-hour blood pressure monitoring instead of just office visits helps people with masked hypertension have better heart and kidney health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1240 (estimated)
• Ages: 35 Years to 80 Years
• Sex: All
• Sponsor: Istituto Auxologico Italiano (Academic / other)
• Locations: 2 sites (Milan and 1 other locations)
• Trial ID: NCT02804074 on ClinicalTrials.gov

What this trial studies

The MASTER study is a 4-year prospective, randomized, open-label, blinded-endpoint study comparing two strategies for managing masked uncontrolled hypertension: one based on office blood pressure (BP) measurements and the other on 24-hour ambulatory BP monitoring. The study aims to determine if the out-of-office BP management approach leads to better cardiovascular and renal outcomes compared to traditional office BP management. Participants will be monitored for changes in left ventricular mass index and urinary albumin excretion during the first year, with follow-ups extending to four years for cardiovascular events and overall health outcomes. This research seeks to provide insights into the most effective management strategies for patients with masked hypertension.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 35-80 with masked uncontrolled hypertension, characterized by normal office BP but elevated out-of-office BP readings.

Not a fit: Patients with severe chronic renal failure, known secondary hypertension, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with masked hypertension, potentially reducing cardiovascular and renal complications.

How similar studies have performed: Other studies have explored similar management strategies for hypertension, indicating potential for success in this approach.

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.

Where this trial is running

Milan and 1 other locations

• Istituto Auxologico Italiano — Milan, Italy (Not_yet_recruiting)
• Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ — Maracaibo, Venezuela (Recruiting)

Study contacts

• Principal investigator: Gianfranco Parati, MD — Istituto Auxologico Italiano
• Study coordinator: Gianfranco Parati, MD

Conditions Masked Hypertension