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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Bolivarian Republic of Venezuela
Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ
RECRUITING
Maracaibo
Italy
Istituto Auxologico Italiano
NOT_YET_RECRUITING
Milan
Contact Information
Primary
Gianfranco Parati, MD
gianfranco.parati@unimib.it
+390261911
Backup
Alberto Zanchetti, MD
alberto.zanchetti@auxologico.it
+390261911
Time Frame
Start Date: 2018-10-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 1240
Treatments
Active_comparator: Group 1
Management strategy of blood pressure based on office BP as a guide to treatment
Experimental: Group 2
Management strategy of blood pressure based on 24-hour ABPM as a guide to treatment
Authors
Gianfranco Gianfranco
Related Therapeutic Areas
Sponsors
Leads: Istituto Auxologico Italiano
Collaborators: European Society of Hypertension

This content was sourced from clinicaltrials.gov