Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism (PULSAR)

University Hospital Basel

Status: Completed

Conditions: Hyperthyroidism; Graves Disease

Treatments: Diagnostic Test: Continuous heart rate monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04932135

EKNZ 2021-00422

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 2 patient groups

Group Treatment

Description:

Patients with newly diagnosed hyperthyroidism due to Graves' disease, if anti thyroid drug treatment is planned.

Treatment:

Diagnostic Test: Continuous heart rate monitoring

Group Surveillance

Description:

Patients suffering from Graves' disease in whom discontinuation of the anti-thyroid therapy is planned.

Treatment:

Diagnostic Test: Continuous heart rate monitoring