Heart Rate Variability and Hyperthyroidism: Evaluation of... | NCT03393728

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

NCT03393728

Sponsor

Yaounde Central Hospital

Status

Completed

Last Update Posted

Jan 8, 2018Actual

Enrollment

10Actual

Phase

Phase 4

Conditions

Hyperthyroidism

Interventions

Propanolol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2008Actual

Primary Completion Date

Dec 30, 2008Actual

Completion Date

Sep 30, 2009Actual

First Submitted Date

Dec 21, 2017

First Submission Date that Met QC Criteria

Jan 5, 2018

First Posted Date

Jan 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2018

Last Update Posted Date

Jan 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sobngwi Eugene, Professor of Endocrinology and Metabolism, Yaounde Central HospitalPrincipal Investigator

Lead Sponsor

Yaounde Central HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

The study questions the systematic adjunction of Propanolol early in the treatment of hyperthyroidism.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	72-hour propanolol before specific treatment of hyperthyroidism	Drug: Propanolol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propanolol	Drug	72-hour propanolol before specific treatment of hyperthyroidism	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Heart rate	Heart rate	72 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29471876	Derived	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.

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols