Hypertension, Plasma Renin Activity
Conditions
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.
Interventions
DRUGHydrochlorothiazide
DRUGLisinopril
DRUGAmlodipine
DRUGmetoprolol
DRUGlisinopril/hydrochlorothiazide
This is a combination pill
Sponsors
Cornell University
Wake Forest University Health Sciences
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Hydrochlorothiazide
Lisinopril
Amlodipine
metoprolol | 7 |
| 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.
Amlodipine
metoprolol
lisinopril/hydrochlorothiazide | 10 |
| Total | 17 |
Baseline characteristics
| Characteristic | PRA-guided Therapy | Fixed-dose Combination Treatment-guided Therapy | Total |
|---|---|---|---|
| Age, Continuous | 47.6 years | 46.7 years | 47 years |
| Region of Enrollment United States | 7 participants | 10 participants | 17 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 7 | 4 / 10 |
| serious Total, serious adverse events | 0 / 7 | 0 / 10 |
Outcome results
Primary
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.
Time frame: 4 months
Population: 6 participants withdrawn before study completion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRA-guided Therapy | Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic | 3 participants |
| Fixed-dose Combination Treatment-guided Therapy | Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic | 1 participants |