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Is a Low Thyreotropin Level Predictive of Recurrent Arrhythmia After Catheter Ablative Surgery? (TABLAS)

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ClinicalTrials.gov Identifier: NCT01789541
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Peter Giesecke, M.D, Karolinska Institutet

Tracking Information
First Submitted Date February 5, 2013
First Posted Date February 12, 2013
Last Update Posted Date January 20, 2016
Study Start Date February 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2013)
Prevalence of subclinical hyperthyroidism in patients undergoing atrial fibrillation ablation [ Time Frame: 1 day (Measured upon inclusion) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 11, 2013)
Recurrent atrial fibrillation after ablation [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Is a Low Thyreotropin Level Predictive of Recurrent Arrhythmia After Catheter Ablative Surgery?
Official Title Observational Prospective Case-control Study on Prevalence and Impact of Subclinical Hyperthyroidism in Patients Undergoing Atrial Fibrillation Ablation
Brief Summary

Overt hyperthyroidism (so-called "goiter" in lay language) is a hormonal disturbance that is known to increase the risk of atrial fibrillation (a common heart arrhythmia with potentially severe consequences) in some patients. Previous research has indicated that even slight elevations in thyroid hormone levels - so called subclinical hyperthyroidism - may increase this risk. When atrial fibrillation and overt hyperthyroidism are found simultaneously in a patient, the hormonal imbalance must be treated first in order to later resolve the arrhythmia. It is unclear whether this strategy holds true for subclinical hyperthyroidism. Our two hypotheses are: 1) Subclinical hyperthyroidism is more prevalent in patients admitted for atrial fibrillation ablation than in the population as a whole, and 2) Patients with subclinical hyperthyroidism and atrial fibrillation benefit less from ablation than others.

As a control group, we have chosen patients admitted for ablation of AV-nodal Reentry Tachycardia at the same clinics as the cases. No correlation has ever been shown between AV-nodal Reentry Tachycardia and hyperthyroidism.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with atrial fibrillation (cases) or AV-nodal reentry tachycardia (controls)
Condition
  • Atrial Fibrillation
  • Subclinical Hyperthyroidism
Intervention Not Provided
Study Groups/Cohorts
  • Atrial fibrillation
    Patients with atrial fibrillation undergoing ablation
  • AV-nodal reentry tachycardia
    Patients with AV-Nodal Reentry Tachycardia undergoing ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 19, 2016)
327
Original Estimated Enrollment
 (submitted: February 11, 2013)
458
Actual Study Completion Date November 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Atrial fibrillation or AV-nodal reentry tachycardia
  • Fulfills criteria for ablation (severe arrhythmia symptoms; for atrial fibrillation patients, having tried at least one antiarrhythmic agent with poor effect)
  • Admitted for ablation for the first time
  • Has left blood samples for thyroid status (TSH, free T4, free T3)

Exclusion Criteria:

  • Atrial flutter
  • Overt hyperthyroidism
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01789541
Other Study ID Numbers 3/9A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Peter Giesecke, M.D, Karolinska Institutet
Study Sponsor Karolinska Institutet
Collaborators Not Provided
Investigators
Study Chair: Mårten Rosenqvist, Professor Karolinska Institutet, Institutionen för kliniska vetenskaper vid Danderyds sjukhus
PRS Account Karolinska Institutet
Verification Date January 2016