HyperthyroidismPULSARNCT04932135
Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
An observational study of Hyperthyroidism and Graves Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperthyroidism, Graves Disease
- What is being tested?
- Continuous heart rate monitoring
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Jun 2021to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Graves' disease at the beginning and after cessation of anti-thyroid drug treatment
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hyperthyroidism, Graves Disease
- Being tested
- Continuous heart rate monitoring
- Keywords
- Heart rate; Pulse rate
- Medical subject headings
- Hyperthyroidism, Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous heart rate monitoringDiagnostic test
Also called Regular measurements of thyroid hormone levels
Continuous heart rate monitoring with a wrist worn fitnesstracker
| Study group | Role | What they receive |
|---|---|---|
| Group Treatment | Patients with newly diagnosed hyperthyroidism due to Graves' disease, if anti thyroid drug treatment is planned. Receives: Diagnostic Test: Continuous heart rate monitoring | |
| Group Surveillance | Patients suffering from Graves' disease in whom discontinuation of the anti-thyroid therapy is planned. Receives: Diagnostic Test: Continuous heart rate monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start8 Jun 2021
- Primary completion21 Mar 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932135
- Sponsor's protocol ID
- EKNZ 2021-00422
- Acronym
- PULSAR
- Status last verified
- Oct 2023
- First submitted
- 14 Jun 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
- ClinicalTrials.gov ID
- NCT04932135
- Acronym / sponsor ID
- PULSAR / EKNZ 2021-00422
- Conditions
- Hyperthyroidism, Graves Disease
- Keywords
- Heart rate; Pulse rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Treatment | – | Diagnostic Test: Continuous heart rate monitoringPatients with newly diagnosed hyperthyroidism due to Graves' disease, if anti thyroid drug treatment is planned. |
| Group Surveillance | – | Diagnostic Test: Continuous heart rate monitoringPatients suffering from Graves' disease in whom discontinuation of the anti-thyroid therapy is planned. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Graves' disease at the beginning and after cessation of anti-thyroid drug treatment
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous heart rate monitoringAlso: Regular measurements of thyroid hormone levelsContinuous heart rate monitoring with a wrist worn fitnesstracker | Diagnostic test | Group Surveillance, Group Treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism and Graves Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting heart rate (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.