Subclinical HyperthyroidismNCT00213720
Treatment of Subclinical Hyperthyroidism
An observational study of Subclinical Hyperthyroidism and Atrial Fibrillation, run by University Hospital, Strasbourg, France at 21 sites in France.
Trial summary
Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate of atrial fibrillation, the main complication of this condition. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subclinical Hyperthyroidism, Atrial Fibrillation
- How many people
- 145 participants
- Where
- 21 sitesFrance
- Study dates
- Aug 2005to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients referred to tertiary hospitals for advice on thyroïd disease
Who may be able to join
- Men and women aged 50 and greater
- Isolated decreased thyroid-stimulating hormone (TSH) with normal FT4 and FT3 levels
Who cannot join
- Iodide overload
- Non sinusal heart rhythm
- Severe heart disease
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Patrick Roger
Bordeaux
Philippe Thiéblot
Clermont-Ferrand
Jean-Marcel Brun
Dijon
Jean-Louis Wemeau
Lille
Marie-Pierre Teissier
Limoges
Jacques Orgiazzi
Lyon
Bernard Conte-Delvox
Marseille
CH de Montbrison
Montbrison, 42605
Jacques Bringer
Montpellier
Marc Klein
Nancy
Michel Rodier
Nîmes
Laurence Leenhardt
Paris
Richard Marechaud
Poitiers
Brigitte Delemer
Reims
Claire Schvartz
Reims
Jean-Marc Kuhn
Rouen
Bruno Estour
Saint-Etienne
Centre Paul Strauss
Strasbourg, 67000
Hopitaux Universitaires de Strasbourg
Strasbourg
Philippe Caron
Toulouse
Pierre Lecomte
Tours
About this study
Official title: Place de l'Iode RadioActif Dans l'HyperThyroïdiE Sub-clinique (PIRHATES)/ Evaluation of the Interest of Subclinical Hyperthyroidism Treatment
Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate of atrial fibrillation, the main complication of this condition.
Read the detailed description
Randomized open-labelled multicentre study comparing radioiodine vs medical supervision without treatment
- Conditions
- Subclinical Hyperthyroidism, Atrial Fibrillation
- Keywords
- Hyperthyroidism, atrial fibrillation, quality of life, radioiodine treatment
- Medical subject headings
- Atrial Fibrillation, Hyperthyroidism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionNov 2019
- Study completionJan 2020
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical HyperthyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Goichot, MD, Principal investigator, Hopitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213720
- Sponsor's protocol ID
- 3463
- Status last verified
- Aug 2019
- First submitted
- 13 Sep 2005
- Last updated
- 29 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place de l'Iode RadioActif Dans l'HyperThyroïdiE Sub-clinique (PIRHATES)/ Evaluation of the Interest of Subclinical Hyperthyroidism Treatment
- ClinicalTrials.gov ID
- NCT00213720
- Acronym / sponsor ID
- 3463
- Conditions
- Subclinical Hyperthyroidism, Atrial Fibrillation
- Keywords
- Hyperthyroidism, atrial fibrillation, quality of life, radioiodine treatment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients referred to tertiary hospitals for advice on thyroïd disease
Key inclusion criteria (2 listed)
- Men and women aged 50 and greater
- Isolated decreased thyroid-stimulating hormone (TSH) with normal FT4 and FT3 levels
Key exclusion criteria (3 listed)
- Iodide overload
- Non sinusal heart rhythm
- Severe heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Goichot, MD principal investigator
Hopitaux Universitaires de Strasbourg
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Hyperthyroidism and Atrial Fibrillation, run by University Hospital, Strasbourg, France at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.