A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension

Not Applicable

Completed

Conditions: Hypertension
Plasma Renin Activity

Interventions: Drug: Hydrochlorothiazide
Drug: Lisinopril
Drug: Amlodipine
Drug: lisinopril/hydrochlorothiazide
Drug: metoprolol

Registration Number: NCT01658657

Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17

Inclusion Criteria

Systolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 150 mmHg, or diastolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 95 mmHg
Not currently taking BP-lowering medication
Clinician recommends pharmacologic treatment
Willing to make necessary study visits
Able to be contacted by phone
Has a primary care clinician
At least 18 years old

Exclusion Criteria

Known secondary cause of hypertension
Pregnancy
Known diabetes, coronary artery disease or renal disease
Known sulfonamide allergy or history of gout
Participant's clinician recommends he/she not enroll
Hyponatremia, hypokalemia, hypernatremia, or hyperglycemia at baseline visit
Baseline visit systolic visit BP average < 140 mmHg and diastolic BP average < 90 mm Hg
Resting heart rate < 55 beats per minute

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRA-guided therapy	Hydrochlorothiazide	Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
PRA-guided therapy	Lisinopril	Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
PRA-guided therapy	Amlodipine	Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
Fixed-dose combination treatment-guided therapy	lisinopril/hydrochlorothiazide	Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
PRA-guided therapy	metoprolol	Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.
Fixed-dose combination treatment-guided therapy	Amlodipine	Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.
Fixed-dose combination treatment-guided therapy	metoprolol	Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.

Primary Outcome Measures

Name	Time	Method
Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic	4 months	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.

Secondary Outcome Measures