Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

University Hospital, Basel, Switzerland1 site in 1 country35 target enrollmentJune 8, 2021

ConditionsHyperthyroidism Graves Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hyperthyroidism
Sponsor: University Hospital, Basel, Switzerland
Enrollment: 35
Locations: 1
Primary Endpoint: resting heart rate
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 8, 2021

End Date

October 30, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Basel, Switzerland

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

resting heart rate

Time Frame: 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.