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

University of North Carolina (UNC)

Status: Completed

Conditions: Hypertension; Plasma Renin Activity

Treatments: Drug: Lisinopril; Drug: lisinopril/hydrochlorothiazide; Drug: Hydrochlorothiazide; Drug: metoprolol; Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01658657

12-1133

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

PRA-guided therapy

Experimental group

Description:

Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.

Treatment:

Drug: metoprolol

Drug: Hydrochlorothiazide

Drug: Amlodipine

Drug: Lisinopril

Fixed-dose combination treatment-guided therapy

Active Comparator group

Description:

Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.

Treatment:

Drug: lisinopril/hydrochlorothiazide

Drug: metoprolol

Drug: Amlodipine