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OpenTrials
Completed

NCT Number: NCT01658657

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Plasma Renin Activity Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrochlorothiazide

Drug

Lisinopril

Drug

Amlodipine

Drug

metoprolol

Drug

lisinopril/hydrochlorothiazide

Drug

This is a combination pill

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Cornell University
  • Wake Forest University Health Sciences

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2012
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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