NCT03393728

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2009

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

December 21, 2017

Last Update Submit

January 5, 2018

Conditions

Hyperthyroidism

Keywords

hyperthyroidismheart rate variabilitypropanololAfrica

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    Sympatho vagal tone measures

    72 hours

Secondary Outcomes (1)

  • Heart rate

    72 hours

Study Arms (1)

Intervention

EXPERIMENTAL

72-hour propanolol before specific treatment of hyperthyroidism

Drug: Propanolol

Interventions

PropanololDRUG

72-hour propanolol before specific treatment of hyperthyroidism

Also known as: Avlocardyl
Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29471876DERIVED

MeSH Terms

Conditions

Hyperthyroidism

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Jean Claude N Mbanya, MD, PhD

    Yaounde Central Hospital and University of Yaounde 1

    STUDY CHAIR

  • Eugène Sobngwi

    Hôpital Central de Yaoundé et Université de Yaoundé 1

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label Before and After design
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endocrinology and Metabolism

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 8, 2018

Study Start

September 1, 2008

Primary Completion

December 30, 2008

Study Completion

September 30, 2009

Last Updated

January 8, 2018

Record last verified: 2018-01