Hypertension Clinical Trial
— GYMNsOfficial title:
A Randomized Controlled Trial Comparing Unattended Automated Office Blood Pressure vs. Home Blood Pressure vs. Central Blood Pressure Monitoring for the Management of Hypertension
Patients with uncontrolled or newly diagnosed hypertension will be randomized to have hypertension management decisions made on the basis of the unattended automated blood pressure (uAOBP) , home BP, and central BP monitoring. This study evaluates the optimal guiding strategy for hypertension will help define which BP monitoring is the most effective strategy to guide the clinical management of hypertension.
Status | Recruiting |
Enrollment | 252 |
Est. completion date | March 1, 2020 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 20 to 90 years of age - nonpregnant - receiving antihypertensive therapy for uncomplicated essential hypertension and taking =1 but = 2 types antihypertensive drugs (to rule out complicated or resistant hypertension) or hypertension newly diagnosed by uAOBP (uAOBP >130 mmHg at screening visit) Exclusion Criteria: - Poor adherence to medication - unable to conduct self-measurement blood pressure - history of polycystic kidney disease - congestive heart failure (a recent assessment of left ventricular ejection fraction < 40% prior to screening visit) - chronic kidney disease with estimated glomerular filtration rate < 30 mL/min/1.73m2 (MDRD) at screening visit - a recent document of severely abnormal left ventricular mass index (>59 g/m2.7 in women and >64 g/m2.7 in men) prior to screening visit - secondary causes of hypertension - uncontrolled hypertension (uAOBP >180/100 mm Hg at screening visit) - history of severe aortic valve disease - history of upper limb obstructive atherosclerosis - history of atrial fibrillation - BP Differences more than 5 mmHg between both arms at screening visit |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24 hour mean ambulatory systolic blood pressure | The change of 24 hour mean ambulatory systolic blood pressure (SBP) | 3 months | |
Secondary | 24 hour mean ambulatory diastolic blood pressure | The change of 24 hour mean ambulatory diastolic blood pressure (DBP) | 3 months | |
Secondary | left ventricular mass | decrease of left ventricular mass | 12 months | |
Secondary | SBP and DBP | change of SBP/DBP measured by uAOBP monitoring, home BP monitoring, or central BP monitoring | 12 months |
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