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CompletedNCT04932135PULSARUpdated Oct 31, 2023

Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism

An observational study in Hyperthyroidism and Graves Disease, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-31.

Primary conditionGraves DiseaseRegistry: HyperthyroidismReclassifiedWhy we changed it
Registry
Hyperthyroidism — the first condition term the registry derived for this study.
ClinicalTrials.gg
Graves Disease
Why
  1. The study's listed conditions name Graves Disease, a narrower term within Hyperthyroidism.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperthyroidism
  • Graves Disease

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Keywords

  • Heart rate; Pulse rate
03

In context

Graves Disease Reclassified

162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

This study's enrollment of 35 is below the median of 120 across 56 observational studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.

Compared within Graves Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hyperthyroidism. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All participants:

  • 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
  • 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

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group Treatment

    Patients with newly diagnosed hyperthyroidism due to Graves' disease, if anti thyroid drug treatment is planned.

    Diagnostic Test: Continuous heart rate monitoring

  • Group Surveillance

    Patients suffering from Graves' disease in whom discontinuation of the anti-thyroid therapy is planned.

    Diagnostic Test: Continuous heart rate monitoring

Interventions

  • Diagnostic testContinuous heart rate monitoring

    Continuous heart rate monitoring with a wrist worn fitnesstracker

    Also known as: Regular measurements of thyroid hormone levels

06

What researchers measure

Primary outcomes

  1. resting heart rate

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

    Time frame: four months

07

Study locations

1 site
  • University Hospital Basel
    Basel, 4031, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04932135
Responsible party
Sponsor
First posted
Jun 18, 2021
Start date
Jun 8, 2021
Primary completion
Mar 21, 2023
Completion
Oct 30, 2023
Last update
Oct 31, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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