Mechanisms of Refractory Hypertension (Reserpine)
Purpose
The study is deigned to determine if refractory hypertension is attributable to heightened sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic agent, in patients failing other classes of antihypertensive agents.
Condition
- Refractory Hypertension
Eligibility
- Eligible Ages
- Between 19 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone
Exclusion Criteria
- congestive heart failure (EF 40%) - chronic kidney disease (GFR <40 ml/min/1.73 mm) - stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months - ongoing depression - active peptic ulcer disease - bradycardia <50 beats per minute - 2nd or 3rd degree heart block - known intolerance of reserpine - use of digoxin or tricycle antidepressants
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open-label, dose titration study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Reserpine |
Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks. |
|
More Details
- Status
- Completed
- Sponsor
- University of Alabama at Birmingham
Study Contact
Detailed Description
Patients with refractory hypertension, defined as uncontrolled office blood pressure despite use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone. After withdrawal from other centrally-acting agents if needed, enrolled patients will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. Twenty-four hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week treatment period. All other antihypertensive medications will remain unchanged during the 4-week treatment period. The primary endpoint will be change in 24-hr ambulatory systolic blood pressure.