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

  • STATUS
    Recruiting
  • End date
    Jan 2, 2023
  • participants needed
    1240
  • sponsor
    Istituto Auxologico Italiano
Updated on 2 September 2021
antihypertensive drugs
uncontrolled hypertension

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).

Details
Condition Hypertension, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Masked Hypertension
Treatment Optimization of antihypertensive treatment based on office BP, Optimization of antihypertensive treatment based on 24-hour ABPM
Clinical Study IdentifierNCT02804074
SponsorIstituto Auxologico Italiano
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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
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