Managing masked hypertension with different blood pressure measurement methods

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ
  Maracaibo, Venezuela Recruiting
• Istituto Auxologico Italiano
  Milan, Italy Not yet recruiting

Study contacts

• Principal investigator: Gianfranco Parati, MD — Istituto Auxologico Italiano
• Study coordinator: Gianfranco Parati, MD
• Email: gianfranco.parati@unimib.it
• Phone: +390261911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.