Is a Low Thyreotropin Level Predictive of Recurrent Arrhythmia After Catheter Ablative Surgery? (TABLAS)
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Purpose
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.
| Condition |
|---|
|
Atrial Fibrillation Subclinical Hyperthyroidism |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Observational Prospective Case-control Study on Prevalence and Impact of Subclinical Hyperthyroidism in Patients Undergoing Atrial Fibrillation Ablation |
- Prevalence of subclinical hyperthyroidism in patients undergoing atrial fibrillation ablation [ Time Frame: 1 day (Measured upon inclusion) ] [ Designated as safety issue: No ]
- Recurrent atrial fibrillation after ablation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 458 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Atrial fibrillation
Patients with atrial fibrillation undergoing ablation
|
|
AV-nodal reentry tachycardia
Patients with AV-Nodal Reentry Tachycardia undergoing ablation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with atrial fibrillation (cases) or AV-nodal reentry tachycardia (controls)
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
Contacts and Locations| Contact: Peter Giesecke, M.D. | +46 70 768 43 88 | peter.giesecke@ds.se |
| Sweden | |
| Stockholm Arrhythmia Center | Recruiting |
| Stockholm, Sweden, 11861 | |
| Contact: Fariborz Tabrizi, M.D. +46 8 616 52 00 | |
| Hjärtkliniken, Karolinska Universitetssjukhuset Huddinge | Recruiting |
| Stockholm, Sweden, 14147 | |
| Contact: Mats Jensen-Urstad, M.D. +46 8 5858 00 00 | |
| Study Chair: | Mårten Rosenqvist, Professor | Karolinska Institutet, Institutionen för kliniska vetenskaper vid Danderyds sjukhus |
More Information
No publications provided
| Responsible Party: | Peter Giesecke, M.D, M.D., Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01789541 History of Changes |
| Other Study ID Numbers: | 3/9A |
| Study First Received: | February 5, 2013 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board Sweden: The National Board of Health and Welfare |
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 June 17, 2013