A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
The purpose of this study is to investigate the effect of plasma renin activity-guided therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that can be measured to determine your hypertension subtype. Once the subtype is known, doctors can prescribe specific medications to target your specific hypertension subtype. This study will investigate whether targeting the specific hypertension subtype helps to achieve blood pressure control sooner and with fewer medications compared to a standard fixed dose combination therapy.
Plasma Renin Activity
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension|
- Blood pressure control, as defined as office BP measurement of <140 mmHg systolic and <90 mmHg diastolic [ Time Frame: 4 months ] [ Designated as safety issue: No ]At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: PRA-guided therapy
Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
|Drug: Hydrochlorothiazide Drug: Lisinopril Drug: Amlodipine Drug: metoprolol|
Active Comparator: Fixed-dose combination treatment-guided therapy
Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
|Drug: Amlodipine Drug: metoprolol Drug: lisinopril/hydrochlorothiazide|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658657
|United States, North Carolina|
|UNC Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Anthony Viera, MD, MPH||Distinguished Associate Professor, Family Medicine|