Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

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.

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Key information

Conditions

Hyperthyroidism Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous heart rate monitoring

Diagnostic Test

Continuous heart rate monitoring with a wrist worn fitnesstracker

Other names: Regular measurements of thyroid hormone levels

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: PULSAR

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jun 18, 2021
Registry last updated: Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed