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

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ClinicalTrials.gov Identifier: NCT02804074
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : June 12, 2020
Sponsor:
Collaborator:
European Society of Hypertension
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Brief 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).

Condition or disease Intervention/treatment Phase
Masked Hypertension Other: Optimization of antihypertensive treatment based on office BP Other: Optimization of antihypertensive treatment based on 24-hour ABPM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
Management strategy of blood pressure based on office BP as a guide to treatment
Other: Optimization of antihypertensive treatment based on office BP
Optimization of antihypertensive treatment based on office BP

Experimental: Group 2
Management strategy of blood pressure based on 24-hour ABPM as a guide to treatment
Other: Optimization of antihypertensive treatment based on 24-hour ABPM
Optimization of antihypertensive treatment based on 24-hour ABPM




Primary Outcome Measures :
  1. changes in LVMI (co-primary endpoint) [ Time Frame: 12 months ]
  2. UAE (albumin/creatinine ratio, co-primary end-point) [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804074


Contacts
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Contact: Gianfranco Parati, MD +390261911 ext 2890 gianfranco.parati@unimib.it
Contact: Alberto Zanchetti, MD +390261911 ext 2901 alberto.zanchetti@auxologico.it

Locations
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Italy
Istituto Auxologico Italiano Not yet recruiting
Milan, Italy
Contact: Gianfranco Parati, MD    390261911 ext 2890    gianfranco.parati@unimib.it   
Venezuela
Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ Recruiting
Maracaibo, Venezuela
Contact: Egle Silva, MD         
Sponsors and Collaborators
Istituto Auxologico Italiano
European Society of Hypertension
Investigators
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Principal Investigator: Gianfranco Parati, MD Istituto Auxologico Italiano
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT02804074    
Other Study ID Numbers: 09A503
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Masked Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents