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Sympathetic Nervous System Modulation in Hypertension

Primary Purpose

Hypertension

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metoprolol Succinate
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, sympathetic nervous system

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker

Exclusion Criteria:

  • Known valvular heart disease of more than mild severity
  • Known coronary artery disease defined by an angiographic coronary artery stenosis greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial infarction, or previous coronary revascularization
  • Known non-ischemic cardiomyopathy with left ventricular ejection fraction less than 50%
  • Atrial fibrillation
  • Current treatment with a β-adrenergic blocking drug or a calcium channel blocker
  • Current treatment with a psychoactive or other drug known to alter 123I-MIBG uptake
  • Participation in another research study within the prior 30 days
  • A life-limiting disease process that is likely to preclude completion of study participation
  • Pregnancy or breast feeding
  • Inability or unwillingness to provide informed consent
  • Baseline resting heart rate less than 65 beats per minute
  • Diabetes
  • Iodine allergy
  • Unwilling to sign informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    metoprolol succinate

    Arm Description

    Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.

    Outcomes

    Primary Outcome Measures

    Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio
    24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2007
    Last Updated
    February 2, 2018
    Sponsor
    University of Cincinnati
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00491387
    Brief Title
    Sympathetic Nervous System Modulation in Hypertension
    Official Title
    Sympathetic Nervous System Modulation in Hypertension by Beta-adrenergic Blockade
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Adverse events reported with beta-blockers as primary therapy.
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Cincinnati

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.
    Detailed Description
    Patients were to receive sympathetic cardiac innervation testing with I-123 MIBG at baseline and again after receiving a titrate dose of beta-blocker. Data were to be assesses by repeated measures testing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    hypertension, sympathetic nervous system

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    metoprolol succinate
    Arm Type
    Experimental
    Arm Description
    Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.
    Intervention Type
    Drug
    Intervention Name(s)
    Metoprolol Succinate
    Other Intervention Name(s)
    Toprol XL, metoprolol XR
    Intervention Description
    Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute.
    Primary Outcome Measure Information:
    Title
    Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio
    Description
    24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.
    Time Frame
    january 2018

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker Exclusion Criteria: Known valvular heart disease of more than mild severity Known coronary artery disease defined by an angiographic coronary artery stenosis greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial infarction, or previous coronary revascularization Known non-ischemic cardiomyopathy with left ventricular ejection fraction less than 50% Atrial fibrillation Current treatment with a β-adrenergic blocking drug or a calcium channel blocker Current treatment with a psychoactive or other drug known to alter 123I-MIBG uptake Participation in another research study within the prior 30 days A life-limiting disease process that is likely to preclude completion of study participation Pregnancy or breast feeding Inability or unwillingness to provide informed consent Baseline resting heart rate less than 65 beats per minute Diabetes Iodine allergy Unwilling to sign informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Myron C Gerson, M.D.
    Organizational Affiliation
    University of Cincinnati
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Sympathetic Nervous System Modulation in Hypertension

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