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OpenTrials
Completed

NCT Number: NCT01789541

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hjärtkliniken, Karolinska Universitetssjukhuset Huddinge, Stockholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of subclinical hyperthyroidism in patients undergoing atrial fibrillation ablation

    Time frame: 1 day (Measured upon inclusion)

Secondary outcomes

  1. Recurrent atrial fibrillation after ablation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Observational Prospective Case-control Study on Prevalence and Impact of Subclinical Hyperthyroidism in Patients Undergoing Atrial Fibrillation Ablation

Acronym: TABLAS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2013
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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