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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01789541
Other study ID # 3/9A
Secondary ID
Status Completed
Phase N/A
First received February 5, 2013
Last updated January 19, 2016
Start date February 2013
Est. completion date November 2015

Study information

Verified date January 2016
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review BoardSweden: The National Board of Health and Welfare
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 327
Est. completion date November 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Sweden Hjärtkliniken, Karolinska Universitetssjukhuset Huddinge Stockholm
Sweden Stockholm Arrhythmia Center Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of subclinical hyperthyroidism in patients undergoing atrial fibrillation ablation 1 day (Measured upon inclusion) No
Secondary Recurrent atrial fibrillation after ablation 6 months No
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