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

NCT ID: NCT01658657

Last Updated: 2015-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-07-31

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.

Conditions

Hypertension; Plasma Renin Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hydrochlorothiazide

Intervention Type: DRUG

Lisinopril

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

metoprolol

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

metoprolol

Intervention Type: DRUG

lisinopril/hydrochlorothiazide

Intervention Type: DRUG

This is a combination pill

Interventions

Hydrochlorothiazide

Intervention Type: DRUG

Lisinopril

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

metoprolol

Intervention Type: DRUG

lisinopril/hydrochlorothiazide

This is a combination pill

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cornell University

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Anthony J Viera, MD, MPH

Distinguished Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Viera, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Distinguished Associate Professor, Family Medicine

Locations

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

12-1133

Identifier Type: -

Identifier Source: org_study_id