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Mechanisms of Refractory Hypertension (Reserpine)

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ClinicalTrials.gov Identifier: NCT03223272
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
David Calhoun, 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.

Condition or disease Intervention/treatment Phase
Refractory Hypertension Drug: Reserpine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, dose titration study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanisms of Refractory Hypertension (Reserpine)
Actual Study Start Date : July 23, 2015
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Reserpine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Ambulatory Systolic Blood Pressure [ Time Frame: 8 weeks ]
    Twenty-four ambulatory systolic blood pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223272


Contacts
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Contact: David A Calhoun, MD 205-934-9281 dcalhoun@uab.edu
Contact: Felice Y Cook, BA 205-934-1400 fycook@uab.edu

Locations
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United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35292
Contact: David A Calhoun, MD    205-934-9281    dcalhoun@uab.edu   
Contact: Felice Y Cook, BA    205-934-1400    fycook@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: David A Calhoun, MD University of Alabama at Birmingham

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Responsible Party: David Calhoun, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03223272     History of Changes
Other Study ID Numbers: 130822008
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: One year after study completion, de-identified subject demographic data and primary outcome data will be available by request.
Supporting Materials: Study Protocol
Time Frame: One year after study completion
Access Criteria: By request.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by David Calhoun, University of Alabama at Birmingham:
hypertension
sympathetic tone
resperpine

Additional relevant MeSH terms:
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Reserpine
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents