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

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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.

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.

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
We found this trial at
1
site
UAB
Birmingham, Alabama 35233
Phone: 205-934-9281
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Birmingham, AL
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