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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Hypertension Plasma Renin Activity
Intervention	Drug: Hydrochlorothiazide Drug: Lisinopril Drug: Amlodipine Drug: metoprolol Drug: lisinopril/hydrochlorothiazide
Phase	N/A
Sponsor	University of North Carolina, Chapel Hill
Responsible Party	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier	NCT01658657
First Received	July 31, 2012
Last Updated	April 7, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	July 31, 2012
Last Updated Date	April 7, 2014
Start Date	October 2012
Estimated Primary Completion Date	June 2014
Current Primary Outcome Measures	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.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
Official Title	A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
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 Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Hypertension Plasma Renin Activity
Intervention	Drug: Hydrochlorothiazide Drug: Lisinopril Drug: Amlodipine Drug: metoprolol Drug: lisinopril/hydrochlorothiazide
Study Arm (s)	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. 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	24
Estimated Completion Date	June 2014
Estimated Primary Completion Date	June 2014
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01658657
Other Study ID Numbers	12-1133
Has Data Monitoring Committee	No
Information Provided By	University of North Carolina, Chapel Hill
Study Sponsor	University of North Carolina, Chapel Hill
Collaborators	Cornell University Wake Forest School of Medicine
Investigators	Principal Investigator: Anthony Viera, MD, MPH Distinguished Associate Professor, Family Medicine
Verification Date	April 2014

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