Treatment of Subclinical Hyperthyroidism | NCT00213720

Studies
Treatment of Subclinical Hyperthyroidism

NCT00213720

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Sep 29, 2020Actual

Enrollment

145Actual

Phase

Not provided

Conditions

Subclinical Hyperthyroidism
Atrial Fibrillation

Interventions

Not provided

Countries

France

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment difficulties

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Nov 2019Actual

Completion Date

Jan 2020Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

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

Sep 25, 2020

Last Update Posted Date

Sep 29, 2020Actual

Description Module

Brief Summary

Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate of atrial fibrillation, the main complication of this condition.

Detailed Description

Randomized open-labelled multicentre study comparing radioiodine vs medical supervision without treatment

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

145Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women aged 50 and greater
Isolated decreased thyroid-stimulating hormone (TSH) with normal FT4 and FT3 levels

Exclusion Criteria:

Iodide overload
Non sinusal heart rhythm
Severe heart disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients referred to tertiary hospitals for advice on thyroïd disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard Goichot, MD	Hopitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Patrick Roger		Bordeaux			France
Philippe Thiéblot

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D006980	Hyperthyroidism

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided