Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism (PULSAR)

October 30, 2023 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Graves' disease at the beginning and after cessation of anti-thyroid drug treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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:
  • Regular measurements of thyroid hormone levels
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:
  • Regular measurements of thyroid hormone levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Actual)

March 21, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 2021-00422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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