NCT04932135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

June 14, 2021

Last Update Submit

October 30, 2023

Conditions

HyperthyroidismGraves Disease

Keywords

Heart rate; Pulse rate

Outcome Measures

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.

    four months

Study Arms (2)

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

Continuous heart rate monitoringDIAGNOSTIC_TEST

Continuous heart rate monitoring with a wrist worn fitnesstracker

Also known as: Regular measurements of thyroid hormone levels
Group SurveillanceGroup Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

HyperthyroidismGraves Disease

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesExophthalmosOrbital DiseasesEye DiseasesGoiterAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 18, 2021

Study Start

June 8, 2021

Primary Completion

March 21, 2023

Study Completion

October 30, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)