Mechanisms of Refractory Hypertension (Reserpine)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
7 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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