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Treatment of Subclinical Hyperthyroidism

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213720
First received: September 13, 2005
Last updated: April 19, 2012
Last verified: November 2007
  Purpose
Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate of atrial fibrillation, the main complication of this condition.

Condition Phase
Subclinical Hyperthyroidism
Atrial Fibrillation
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Place de l'Iode RadioActif Dans l'HyperThyroïdiE Sub-clinique (PIRHATES)/ Evaluation of the Interest of Subclinical Hyperthyroidism Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Biospecimen Retention:   Samples Without DNA
serum

Estimated Enrollment: 300
Study Start Date: August 2005
Detailed Description:
Randomized open-labelled multicentre study comparing radioiodine vs medical supervision without treatment
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients referred to tertiary hospitals for advice on thyroïd disease
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213720

Locations
France
Patrick Roger
Bordeaux, France
Philippe Thiéblot
Clermont-Ferrand, France
Jean-Marcel Brun
Dijon, France
Jean-Louis Wemeau
Lille, France
Marie-Pierre Teissier
Limoges, France
Jacques Orgiazzi
Lyon, France
Bernard Conte-Delvox
Marseille, France
CH de Montbrison
Montbrison, France, 42605
Jacques Bringer
Montpellier, France
Marc Klein
Nancy, France
Michel Rodier
Nimes, France
Laurence Leenhardt
Paris, France
Richard Marechaud
Poitiers, France
Brigitte Delemer
Reims, France
Claire Schvartz
Reims, France
Didier Maugendre
Rennes, France
Jean-Marc Kuhn
Rouen, France
Bruno Estour
Saint-Etienne, France
Centre Paul Strauss
Strasbourg, France, 67000
Hopitaux Universitaires de Strasbourg
Strasbourg, France
Philippe Caron
Toulouse, France
Pierre Lecomte
Tours, France
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Bernard Goichot, MD Hopitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00213720     History of Changes
Other Study ID Numbers: 3463 
Study First Received: September 13, 2005
Last Updated: April 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
Hyperthyroidism
atrial fibrillation
quality of life
radioiodine treatment

Additional relevant MeSH terms:
Atrial Fibrillation
Hyperthyroidism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 09, 2016