Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism (NCT04932135) | Clinical Trial Compass
CompletedNot Applicable
Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
Switzerland35 participantsStarted 2021-06-08
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.