Mechanisms of Refractory Hypertension (Reserpine)

NCT03223272 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 130822008
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Hypertension

Keywords

hypertension; sympathetic tone; resperpine

Outcome Measures

Primary Outcomes (1)

• Change Ambulatory Systolic Blood Pressure

  Twenty-four hour ambulatory systolic blood pressure

  Baseline and 8 weeks

Study Arms (1)

Reserpine

EXPERIMENTAL

Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.

Drug: Reserpine

Interventions

Reserpine DRUG

Open label reserpine 0.1 mg pill orally

Reserpine

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone

You may not qualify if:

• 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
• nd or 3rd degree heart block
• known intolerance of reserpine
• use of digoxin or tricycle antidepressants

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35292, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Reserpine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Yohimbine; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Physician
• Organization: UAB

dacalhou@sentara.com

4346545260

Study Officials

• David A Calhoun, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open-label, dose titration study

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: July 23, 2015
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: November 30, 2021
• Results First Posted: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after study completion
• Access Criteria: By request.

Locations

US (1)