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
About this trial
This is an interventional treatment trial for Hyperthyroidism focused on measuring hyperthyroidism, heart rate variability, propanolol, Africa
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
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
NCT ID
NCT03393728
First Posted
December 21, 2017
Last Updated
January 5, 2018
Sponsor
Yaounde Central Hospital
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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