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

Masked Hypertension Clinical Trial

— MASTER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02804074
• Other study ID #: 09A503
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Istituto Auxologico Italiano
• Contact: Gianfranco Parati, MD
• Phone: +390261911
• Email: gianfranco.parati[@]unimib.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1240
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Masked Hypertension

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milan
Venezuela	Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ	Maracaibo

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	European Society of Hypertension

Countries where clinical trial is conducted

Italy,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in LVMI (co-primary endpoint)		12 months
Primary	UAE (albumin/creatinine ratio, co-primary end-point)		12 months