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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT04932135
Collaborator
(none)
40
1
21.7
1.8

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
  • Diagnostic Test: Continuous heart rate monitoring

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
Actual Study Start Date :
Jun 8, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

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:
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    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.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT04932135
    Other Study ID Numbers:
    • EKNZ 2021-00422
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Basel, Switzerland
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 5, 2021