Mechanisms of Refractory Hypertension (Reserpine)
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 19 - 80 |
| Updated: | 7/29/2018 |
| Start Date: | July 23, 2015 |
| End Date: | July 30, 2019 |
| Contact: | David A Calhoun, MD |
| Email: | dcalhoun@uab.edu |
| Phone: | 205-934-9281 |
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.
sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic
agent, in patients failing other classes of antihypertensive agents.
Patients with refractory hypertension, defined as uncontrolled office blood pressure despite
use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone,
will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. If tolerated, the dose
of the reserpine will be increased to 0.25 mg daily for an additional 4 weeks. Twenty-four
hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week
treatment period, and at the end of the 8-week treatment period. All other antihypertensive
medications will remain unchanged during the 8-week treatment period. The primary endpoint
will be change in 24-hr ambulatory systolic blood pressure.
use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone,
will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. If tolerated, the dose
of the reserpine will be increased to 0.25 mg daily for an additional 4 weeks. Twenty-four
hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week
treatment period, and at the end of the 8-week treatment period. All other antihypertensive
medications will remain unchanged during the 8-week treatment period. The primary endpoint
will be change in 24-hr ambulatory systolic blood pressure.
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
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