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

Primary Purpose

Masked Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Optimization of antihypertensive treatment based on office BP
Optimization of antihypertensive treatment based on 24-hour ABPM
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Masked Hypertension

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istituto Auxologico Italiano
  • Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

Management strategy of blood pressure based on office BP as a guide to treatment

Management strategy of blood pressure based on 24-hour ABPM as a guide to treatment

Outcomes

Primary Outcome Measures

changes in LVMI (co-primary endpoint)
UAE (albumin/creatinine ratio, co-primary end-point)

Secondary Outcome Measures

Full Information

First Posted
June 14, 2016
Last Updated
February 23, 2023
Sponsor
Istituto Auxologico Italiano
Collaborators
European Society of Hypertension
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1. Study Identification

Unique Protocol Identification Number
NCT02804074
Brief Title
MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement
Acronym
MASTER
Official Title
MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano
Collaborators
European Society of Hypertension

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Masked Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Management strategy of blood pressure based on office BP as a guide to treatment
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Management strategy of blood pressure based on 24-hour ABPM as a guide to treatment
Intervention Type
Other
Intervention Name(s)
Optimization of antihypertensive treatment based on office BP
Intervention Description
Optimization of antihypertensive treatment based on office BP
Intervention Type
Other
Intervention Name(s)
Optimization of antihypertensive treatment based on 24-hour ABPM
Intervention Description
Optimization of antihypertensive treatment based on 24-hour ABPM
Primary Outcome Measure Information:
Title
changes in LVMI (co-primary endpoint)
Time Frame
12 months
Title
UAE (albumin/creatinine ratio, co-primary end-point)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianfranco Parati, MD
Phone
+390261911
Ext
2890
Email
gianfranco.parati@unimib.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Zanchetti, MD
Phone
+390261911
Ext
2901
Email
alberto.zanchetti@auxologico.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianfranco Parati, MD
Organizational Affiliation
Istituto Auxologico Italiano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Auxologico Italiano
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianfranco Parati, MD
Phone
390261911
Ext
2890
Email
gianfranco.parati@unimib.it
Facility Name
Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ
City
Maracaibo
Country
Venezuela
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Egle Silva, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30573476
Citation
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, 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.
Results Reference
derived

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

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