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Opioid Compromise in Hypertension--Modulating Factors

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005434
    Brief Title
    Opioid Compromise in Hypertension--Modulating Factors
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1992 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 1997 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To confirm the preliminary findings of age, race, and hypertension chronicity effects on opioid and cardiovascular responses to stress and to determine the opioid mechanisms mediating these effects using an opioid receptor blockade strategy.
    Detailed Description
    BACKGROUND: Opioids exert depressor effects on cardiovascular responses through sympathetic nervous system inhibition. Research suggests that opioid inhibition of sympathetic activity may be compromised in hypertension. Preliminary studies by the Principal Investigator suggest that the nature of this compromise may be influenced by age and race. Additionally, literature suggests that hypertension chronicity may modulate opioid sympathoinhibitory actions. The receptor mechanisms mediating the observed modulating effects of age, race, and hypertension chronicity on opioidergic inhibition and regulation of blood pressure remained to be determined. DESIGN NARRATIVE: Two double-blind, placebo-controlled cross-over studies were conducted to evaluate the effects of naltrexone hydrochloride, an oral opiate antagonist, on adrenergically-mediated cardiovascular responses in older and younger, Black and White normotensives and hypertensives with varying lengths of hypertension duration. Cardiovascular and opioid responses were measured in response to a stressor combined with either placebo or naltrexone pretreatment. Results from these studies assisted in (a) elucidating opioidergic mechanisms underlying the increased rates of hypertension morbidity and mortality among Blacks and the elderly, and (b) ultimately optimized the design of pharmacological interventions for the prevention and treatment of hypertension. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypertension

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    8641726
    Citation
    Svetkey LP, Timmons PZ, Emovon O, Anderson NB, Preis L, Chen YT. Association of hypertension with beta2- and alpha2c10-adrenergic receptor genotype. Hypertension. 1996 Jun;27(6):1210-5. doi: 10.1161/01.hyp.27.6.1210.
    Results Reference
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    Opioid Compromise in Hypertension--Modulating Factors

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