Skip to main content
OpenTrials
Completed

NCT Number: NCT03223272

Mechanisms of Refractory Hypertension (Reserpine)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UAB

Birmingham, Alabama, 35292, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reserpine

Drug

Open label reserpine 0.1 mg pill orally

Primary outcomes

  1. Change Ambulatory Systolic Blood Pressure

    Time frame: Baseline and 8 weeks

    Twenty-four hour ambulatory systolic blood pressure

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2017
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.