Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

Completed

• Conditions: Graves Disease; Hyperthyroidism
• Interventions: Diagnostic Test: Continuous heart rate monitoring

• Registration Number: NCT04932135
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-08
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-18
• Primary Completion: 2023-03-21
• Status Verified: 2023-10
• Study Completion: 2023-10-30
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group Surveillance	Continuous heart rate monitoring	Patients suffering from Graves' disease in whom discontinuation of the anti-thyroid therapy is planned.
Group Treatment	Continuous heart rate monitoring	Patients with newly diagnosed hyperthyroidism due to Graves' disease, if anti thyroid drug treatment is planned.

Primary Outcome Measures

Name	Time	Method
resting heart rate	four months	continuous resting heart rate measurement with fitnesstracker in relation to the thyroid hormone levels in patients during and after treatment with anti-thyroid drugs.

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland