Skip to content

Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04932135
Acronym
PULSAR
Enrollment
35
Registered
2021-06-18
Start date
2021-06-08
Completion date
2023-10-30
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves Disease, Hyperthyroidism

Keywords

Heart rate; Pulse rate

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.

Interventions

DIAGNOSTIC_TESTContinuous heart rate monitoring

Continuous heart rate monitoring with a wrist worn fitnesstracker

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
resting heart ratefour monthscontinuous resting heart rate measurement with fitnesstracker in relation to the thyroid hormone levels in patients during and after treatment with anti-thyroid drugs.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026