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

NCT01658657 | Completed Results

• 1 other identifier: 12-1133
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Plasma Renin Activity

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic

  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.

  4 months

Study Arms (2)

PRA-guided therapy

EXPERIMENTAL

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

Fixed-dose combination treatment-guided therapy

ACTIVE COMPARATOR

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

Interventions

Hydrochlorothiazide DRUG

PRA-guided therapy

Lisinopril DRUG

PRA-guided therapy

Amlodipine DRUG

Fixed-dose combination treatment-guided therapy; PRA-guided therapy

metoprolol DRUG

Fixed-dose combination treatment-guided therapy; PRA-guided therapy

lisinopril/hydrochlorothiazide DRUG

This is a combination pill

Fixed-dose combination treatment-guided therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Cornell University: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide; Lisinopril; Amlodipine; Metoprolol; hydrochlorothiazide, lisinopril drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Results Point of Contact

• Title: Anthony Viera
• Organization: UNC Chapel Hil

viera@med.unc.edu

919-966-0758

Study Officials

• Anthony Viera, MD, MPH

  Distinguished Associate Professor, Family Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Associate Professor

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 7, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 27, 2015
• Results First Posted: June 22, 2015

Record last verified: 2015-08

Locations

US (1)