PULSAR: Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Group Treatment Patients with newly diagnosed hyperthyroidism due to Graves' disease, if anti thyroid drug treatment is planned. |
Diagnostic Test: Continuous heart rate monitoring
Continuous heart rate monitoring with a wrist worn fitnesstracker
Other Names:
|
Group Surveillance Patients suffering from Graves' disease in whom discontinuation of the anti-thyroid therapy is planned. |
Diagnostic Test: Continuous heart rate monitoring
Continuous heart rate monitoring with a wrist worn fitnesstracker
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Hospital Basel | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EKNZ 2021-00422