Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
NCT ID: NCT04932135
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2021-06-08
2023-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group Treatment
Patients with newly diagnosed hyperthyroidism due to Graves' disease, if anti thyroid drug treatment is planned.
Continuous heart rate monitoring
Continuous heart rate monitoring with a wrist worn fitnesstracker
Group Surveillance
Patients suffering from Graves' disease in whom discontinuation of the anti-thyroid therapy is planned.
Continuous heart rate monitoring
Continuous heart rate monitoring with a wrist worn fitnesstracker
Interventions
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Continuous heart rate monitoring
Continuous heart rate monitoring with a wrist worn fitnesstracker
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 17 to 35 kg/m2
* Diagnosis of Graves' disease (matching one of the following criteria: elevated TRAb and/or ultrasonography and functional imaging consistent with Graves' disease)
* In possession of a smart phone
* Able to use a wearable device and willing to regularly upload their biometric data
* Informed consent as documented by signature (Appendix Informed Consent Form)
Group "treatment":
* TSH \< 0.2 mIU/l and
* fT4 \> 25 pM or fT3 \> 8 pM
* ATD planned, additional treatment with propranolol allowed
Group "surveillance":
* TSH within the reference range between 0.3 and 4.5 mlU/l
* Cessation of ATD is planned within the next 2-4 weeks
Exclusion Criteria
* Treatment with amiodarone
* Pacemaker with continuous stimulation.
* Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
* Abuse of alcohol or illicit drugs
* Allergic to nickel or silicone
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Locations
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University Hospital Basel
Basel, , Switzerland
Countries
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Other Identifiers
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EKNZ 2021-00422
Identifier Type: -
Identifier Source: org_study_id
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