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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Plasma Renin Activity

Intervention / Treatment
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* Drug: Hydrochlorothiazide
* Drug: Lisinopril
* Drug: Amlodipine
* Drug: metoprolol
* Drug: lisinopril/hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRA-guided therapy<br>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<br> <br> Drug: Lisinopril<br> <br> Drug: Amlodipine<br> <br> Drug: metoprolol<br> <br> |
| Active Comparator: Fixed-dose combination treatment-guided therapy<br>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<br> <br> Drug: metoprolol<br> <br> Drug: lisinopril/hydrochlorothiazide<br>* This is a combination pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic | 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. | 4 months |