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

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
Intervention Model
Single Group Assignment
Intervention Model Description
Open-label, dose titration study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Reserpine
Subjects will receive open-label reserpine 0.1 mg daily for - weeks; titrating to 0.25 mg daily for additional 4-weeks
  • Drug: Reserpine
    Open label reserpine 0.1-0.25 mg pill orally

Recruiting Locations

UAB
Birmingham, Alabama 35292
Contact:
David A Calhoun, MD
205-934-9281
dcalhoun@uab.edu

More Details

NCT ID
NCT03223272
Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

David A Calhoun, MD
205-934-9281
dcalhoun@uab.edu

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, 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.