MedDataX Logo

Mechanisms of Refractory Hypertension (Reserpine)

NCT ID: NCT03223272

Last Updated: 2021-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-23

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractory Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hypertension sympathetic tone resperpine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label, dose titration study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reserpine

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

Group Type EXPERIMENTAL

Reserpine

Intervention Type DRUG

Open label reserpine 0.1 mg pill orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reserpine

Open label reserpine 0.1 mg pill orally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Calhoun

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David A Calhoun, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UAB

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

130822008

Identifier Type: -

Identifier Source: org_study_id