BridgeMD
New treatment option for Masked Hypertension
Official title MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement
ClinicalTrials.gov ID: NCT02804074
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 80
You may be able to join if
- Male and female people
- 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
You likely can't join if
- eGFR \ 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
See the full eligibility criteria
- Male and female people
- 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)
- eGFR \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
- Maracaibo, Venezuela
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy; Maracaibo, Venezuela. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.