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

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ClinicalTrials.gov Identifier: NCT01658657
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : June 22, 2015
Last Update Posted : August 27, 2015
Sponsor:
Collaborators:
Cornell University
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Plasma Renin Activity Drug: Hydrochlorothiazide Drug: Lisinopril Drug: Amlodipine Drug: metoprolol Drug: lisinopril/hydrochlorothiazide Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
Study Start Date : October 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 Drug: Amlodipine
Drug: metoprolol
Drug: lisinopril/hydrochlorothiazide
This is a combination pill


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658657


Locations
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United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Cornell University
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Anthony Viera, MD, MPH Distinguished Associate Professor, Family Medicine
More Information
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Responsible Party: Anthony J Viera, MD, MPH, Distinguished Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01658657    
Other Study ID Numbers: 12-1133
First Posted: August 7, 2012    Key Record Dates
Results First Posted: June 22, 2015
Last Update Posted: August 27, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Amlodipine
Hydrochlorothiazide
Lisinopril
Hydrochlorothiazide, lisinopril drug combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
 Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors