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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cornell University
Wake Forest School of Medicine
Information provided by (Responsible Party):
Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01658657
First received: July 31, 2012
Last updated: April 7, 2014
Last verified: April 2014
  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 Intervention
Hypertension
Plasma Renin Activity
Drug: Hydrochlorothiazide
Drug: Lisinopril
Drug: Amlodipine
Drug: metoprolol
Drug: lisinopril/hydrochlorothiazide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

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.


Estimated Enrollment: 24
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658657

Locations
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 School of Medicine
Investigators
Principal Investigator: Anthony Viera, MD, MPH Distinguished Associate Professor, Family Medicine
  More Information

No publications provided

Responsible Party: Anthony J Viera, MD, MPH, Distinguished Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01658657     History of Changes
Other Study ID Numbers: 12-1133
Study First Received: July 31, 2012
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Hydrochlorothiazide
Amlodipine
Lisinopril
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Calcium Channel Blockers
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 25, 2014