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Heart Rate Variability and Hyperthyroidism: Evaluation of the Short-term Effects of Propanolol

Primary Purpose

Hyperthyroidism

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Propanolol
Sponsored by
Yaounde Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperthyroidism focused on measuring hyperthyroidism, heart rate variability, propanolol, Africa

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • consenting patients referred to or diagnosed at the National Centre of Obesity of the Yaounde Central Hospital as having hyperthyroidism
  • naïve of all treatment specific for hyperthyroidism.
  • aged 18-70 years

Exclusion Criteria:

  • Patients already under a specific treatment for hyperthyroidism
  • Patients taking beta blockers or any other cardiospecific treatment
  • Patients presenting complications including acute thyrotoxic crisis, or symptomatic cardiac failure
  • Contraindications to the prescription of beta blockers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    72-hour propanolol before specific treatment of hyperthyroidism

    Outcomes

    Primary Outcome Measures

    Heart rate variability
    Sympatho vagal tone measures

    Secondary Outcome Measures

    Heart rate
    Heart rate

    Full Information

    First Posted
    December 21, 2017
    Last Updated
    January 5, 2018
    Sponsor
    Yaounde Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03393728
    Brief Title
    Heart Rate Variability and Hyperthyroidism: Evaluation of the Short-term Effects of Propanolol
    Official Title
    Short Term Effects of Propanolol on Heart Rate Variability of Hyperthyroidism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2008 (Actual)
    Primary Completion Date
    December 30, 2008 (Actual)
    Study Completion Date
    September 30, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yaounde Central Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism. Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV). Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours.
    Detailed Description
    Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism. Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV). Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours. Other outcomes included mean heart rate, mean R-R interval during 2-hour rest. The study questions the systematic adjunction of Propanolol early in the treatment of hyperthyroidism.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperthyroidism
    Keywords
    hyperthyroidism, heart rate variability, propanolol, Africa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open label Before and After design
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    72-hour propanolol before specific treatment of hyperthyroidism
    Intervention Type
    Drug
    Intervention Name(s)
    Propanolol
    Other Intervention Name(s)
    Avlocardyl
    Intervention Description
    72-hour propanolol before specific treatment of hyperthyroidism
    Primary Outcome Measure Information:
    Title
    Heart rate variability
    Description
    Sympatho vagal tone measures
    Time Frame
    72 hours
    Secondary Outcome Measure Information:
    Title
    Heart rate
    Description
    Heart rate
    Time Frame
    72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: consenting patients referred to or diagnosed at the National Centre of Obesity of the Yaounde Central Hospital as having hyperthyroidism naïve of all treatment specific for hyperthyroidism. aged 18-70 years Exclusion Criteria: Patients already under a specific treatment for hyperthyroidism Patients taking beta blockers or any other cardiospecific treatment Patients presenting complications including acute thyrotoxic crisis, or symptomatic cardiac failure Contraindications to the prescription of beta blockers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean Claude N Mbanya, MD, PhD
    Organizational Affiliation
    Yaounde Central Hospital and University of Yaounde 1
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Eugène Sobngwi
    Organizational Affiliation
    Hôpital Central de Yaoundé et Université de Yaoundé 1
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Availability to researchers making a formal request with restrictions in relation to national regulations on data sharing
    Citations:
    PubMed Identifier
    29471876
    Citation
    Tankeu AT, Azabji-Kenfack M, Nganou CN, Ngassam E, Kuate-Mfeukeu L, Mba C, Dehayem MY, Mbanya JC, Sobngwi E. Effect of propranolol on heart rate variability in hyperthyroidism. BMC Res Notes. 2018 Feb 22;11(1):151. doi: 10.1186/s13104-018-3224-x.
    Results Reference
    derived

    Learn more about this trial

    Heart Rate Variability and Hyperthyroidism: Evaluation of the Short-term Effects of Propanolol

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