Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

Study Overview
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Brief Summary
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The investigators want to investigate if a continuous heart rate monitoring with a wrist worn fitnesstracker can be useful in the treatment and surveillance of patients suffering from Graves' disease.The aim of our research project is two-fold: First, to evaluate the use of continuous heart rate monitoring as a potential substitute for hormone measurements during treatment of hyperthyroidism. Second, to use continuous heart rate monitoring as a tool for early detection of relapse after discontinuation of antithyroid drugs.

Official Title
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Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

Conditions
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Hyperthyroidism, Graves Disease

Intervention / Treatment
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* Diagnostic Test: Continuous heart rate monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants: 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: Chronic treatment with beta blocker or verapamil-type calcium antagonist for other reason than symptomatic treatment of hyperthyroidism (propranolol) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group Treatment<br>Patients with newly diagnosed hyperthyroidism due to Graves' disease, if anti thyroid drug treatment is planned. | Diagnostic Test: Continuous heart rate monitoring<br>* Continuous heart rate monitoring with a wrist worn fitnesstracker<br>* Other names: Regular measurements of thyroid hormone levels;|
| Group Surveillance<br>Patients suffering from Graves' disease in whom discontinuation of the anti-thyroid therapy is planned. | Diagnostic Test: Continuous heart rate monitoring<br>* Continuous heart rate monitoring with a wrist worn fitnesstracker<br>* Other names: Regular measurements of thyroid hormone levels;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting heart rate | continuous resting heart rate measurement with fitnesstracker in relation to the thyroid hormone levels in patients during and after treatment with anti-thyroid drugs. | four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart rate; Pulse rate