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

January 5, 2018 updated by: Sobngwi Eugene, Yaounde Central Hospital

Short Term Effects of Propanolol on Heart Rate Variability of Hyperthyroidism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
72-hour propanolol before specific treatment of hyperthyroidism
Drug: Propanolol
72-hour propanolol before specific treatment of hyperthyroidism
Other Names:
  • Avlocardyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: 72 hours
Sympatho vagal tone measures
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 72 hours
Heart rate
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yaounde Central Hospital

Investigators

  • Study Chair: Jean Claude N Mbanya, MD, PhD, Yaounde Central Hospital and University of Yaounde 1
  • Principal Investigator: Eugène Sobngwi, Hôpital Central de Yaoundé et Université de Yaoundé 1

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2008

Primary Completion (Actual)

December 30, 2008

Study Completion (Actual)

September 30, 2009

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YaoundeCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Availability to researchers making a formal request with restrictions in relation to national regulations on data sharing

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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