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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658657
First Posted: August 7, 2012
Last Update Posted: August 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cornell University
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill
July 31, 2012
August 7, 2012
June 3, 2015
June 22, 2015
August 27, 2015
October 2012
July 2014   (Final data collection date for primary outcome measure)
Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01658657 on ClinicalTrials.gov Archive Site
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A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension
  • Plasma Renin Activity
  • Drug: Hydrochlorothiazide
  • Drug: Lisinopril
  • Drug: Amlodipine
  • Drug: metoprolol
  • Drug: lisinopril/hydrochlorothiazide
    This is a combination pill
  • 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.
    Interventions:
    • Drug: Hydrochlorothiazide
    • Drug: Lisinopril
    • Drug: Amlodipine
    • Drug: metoprolol
  • 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.
    Interventions:
    • Drug: Amlodipine
    • Drug: metoprolol
    • Drug: lisinopril/hydrochlorothiazide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
July 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01658657
12-1133
No
Not Provided
Not Provided
Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • Cornell University
  • Wake Forest University Health Sciences
Principal Investigator: Anthony Viera, MD, MPH Distinguished Associate Professor, Family Medicine
University of North Carolina, Chapel Hill
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP