Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-31 @ 11:49 PM
Study NCT ID:
NCT04932135
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D006111', 'term': 'Graves Disease'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'resting heart rate', 'timeFrame': 'four months', 'description': 'continuous resting heart rate measurement with fitnesstracker in relation to the thyroid hormone levels in patients during and after treatment with anti-thyroid drugs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart rate; Pulse rate'], 'conditions': ['Hyperthyroidism', 'Graves Disease']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Graves' disease at the beginning and after cessation of anti-thyroid drug treatment", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants:\n\n* BMI 17 to 35 kg/m2\n* Diagnosis of Graves\' disease (matching one of the following criteria: elevated TRAb and/or ultrasonography and functional imaging consistent with Graves\' disease)\n* In possession of a smart phone\n* Able to use a wearable device and willing to regularly upload their biometric data\n* Informed consent as documented by signature (Appendix Informed Consent Form)\n\nGroup "treatment":\n\n* TSH \\< 0.2 mIU/l and\n* fT4 \\> 25 pM or fT3 \\> 8 pM\n* ATD planned, additional treatment with propranolol allowed\n\nGroup "surveillance":\n\n* TSH within the reference range between 0.3 and 4.5 mlU/l\n* Cessation of ATD is planned within the next 2-4 weeks\n\nExclusion Criteria:\n\n* Chronic treatment with beta blocker or verapamil-type calcium antagonist for other reason than symptomatic treatment of hyperthyroidism (propranolol)\n* Treatment with amiodarone\n* Pacemaker with continuous stimulation.\n* Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer\n* Abuse of alcohol or illicit drugs\n* Allergic to nickel or silicone\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant'}, 'identificationModule': {'nctId': 'NCT04932135', 'acronym': 'PULSAR', 'briefTitle': 'Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism', 'orgStudyIdInfo': {'id': 'EKNZ 2021-00422'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group Treatment', 'description': "Patients with newly diagnosed hyperthyroidism due to Graves' disease, if anti thyroid drug treatment is planned.", 'interventionNames': ['Diagnostic Test: Continuous heart rate monitoring']}, {'label': 'Group Surveillance', 'description': "Patients suffering from Graves' disease in whom discontinuation of the anti-thyroid therapy is planned.", 'interventionNames': ['Diagnostic Test: Continuous heart rate monitoring']}], 'interventions': [{'name': 'Continuous heart rate monitoring', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Regular measurements of thyroid hormone levels'], 'description': 'Continuous heart rate monitoring with a wrist worn fitnesstracker', 'armGroupLabels': ['Group Surveillance', 'Group Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}