Mechanisms of Refractory Hypertension (Reserpine)

Phase 2

Completed

• Conditions: Refractory Hypertension
• Interventions: Drug: Reserpine

• Registration Number: NCT03223272
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

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. 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.

Study Timeline

• Study Start: 2015-07-23
• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Results First Submitted: 2021-05-06
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-02
• Last Update Submitted: 2021-11-02
• Results First Posted: 2021-11-30
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reserpine	Reserpine	Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change Ambulatory Systolic Blood Pressure	Baseline and 8 weeks	Twenty-four hour ambulatory systolic blood pressure

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States