Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

Graves Disease Clinical Trial

— PULSAR  

Official title:

Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04932135
• Other study ID #: EKNZ 2021-00422
• Status: Completed
• Start date: June 8, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 30, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Graves Disease
• Hyperthyroidism

Intervention

Diagnostic Test:
• Continuous heart rate monitoring
Continuous heart rate monitoring with a wrist worn fitnesstracker

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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