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Recruiting NCT02804074

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

No phase Interventional Masked Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optimization of antihypertensive treatment based on office BP, Optimization of antihypertensive treatment based on 24-hour ABPM.
Who it may be relevant to
Registry conditions: Masked Hypertension. Basic parameters: 35 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy, Venezuela
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Other Optimization of antihypertensive treatment based on office BP
    Optimization of antihypertensive treatment based on office BP
  • Other Optimization of antihypertensive treatment based on 24-hour ABPM
    Optimization of antihypertensive treatment based on 24-hour ABPM

Primary outcome measures

  • changes in LVMI (co-primary endpoint) [Time frame: 12 months]
  • UAE (albumin/creatinine ratio, co-primary end-point) [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Istituto Auxologico Italiano — Milan
Venezuela · 1 center
  • Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares d — Maracaibo

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, Soran PMID 30573476

Identifiers

NCT: NCT02804074 · 09A503

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗