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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

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date June 12, 2020
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • changes in LVMI (co-primary endpoint) [ Time Frame: 12 months ]
  • UAE (albumin/creatinine ratio, co-primary end-point) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement
Official Title  ICMJE MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Masked Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Group 1
    Management strategy of blood pressure based on office BP as a guide to treatment
    Intervention: Other: 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
    Intervention: Other: Optimization of antihypertensive treatment based on 24-hour ABPM
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, Jelaković 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, Soranna D, Stergiou G, Stojanovic M, Tsioufis K, Valsecchi MG, Veglio F, Waisman GD, Wang JG, Wijnmaalen P, Zambon A, Zanchetti A, Zhang Y. MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study: a randomised controlled trial protocol. BMJ Open. 2018 Dec 19;8(12):e021038. doi: 10.1136/bmjopen-2017-021038.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
1240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gianfranco Parati, MD +390261911 ext 2890 gianfranco.parati@unimib.it
Contact: Alberto Zanchetti, MD +390261911 ext 2901 alberto.zanchetti@auxologico.it
Listed Location Countries  ICMJE Italy,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02804074
Other Study ID Numbers  ICMJE 09A503
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Istituto Auxologico Italiano
Study Sponsor  ICMJE Istituto Auxologico Italiano
Collaborators  ICMJE European Society of Hypertension
Investigators  ICMJE
Principal Investigator: Gianfranco Parati, MD Istituto Auxologico Italiano
PRS Account Istituto Auxologico Italiano
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP