Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:49 AM
Study NCT ID:
NCT07375251
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-29
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TELEMACO-S: a Telemonitoring Project in Cardiology and Technology Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-24', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2026-01-24', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the number of hospitalizations for acute heart failure decompensation', 'timeFrame': 'From the start of the study (14 July 2025) until the end of follow-up (31 March 2026), assessed up to approximately 8.5 months (up to 37 weeks)', 'description': 'Hospitalizations for acute heart failure decompensation assessed during the study period. Changes over time in the number of hospitalizations will be evaluated; a multiparametric score will be used to support clinical assessment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'acute decompensated heart failure', 'wearable devices', 'telemonitoring'], 'conditions': ['Heart Failure Patients']}, 'referencesModule': {'references': [{'pmid': '33882601', 'type': 'BACKGROUND', 'citation': 'Indraratna P, Biswas U, Yu J, Schreier G, Ooi SY, Lovell NH, Redmond SJ. Trials and Tribulations: mHealth Clinical Trials in the COVID-19 Pandemic. Yearb Med Inform. 2021 Aug;30(1):272-279. doi: 10.1055/s-0041-1726487. Epub 2021 Apr 21.'}, {'pmid': '39603408', 'type': 'BACKGROUND', 'citation': 'Docherty KF, Buendia Lopez R, Folkvaljon F, Boer RA, Chen J, Hammarstedt A, Kitzman DW, Kosiborod MN, Langkilde AM, Reicher B, Senni M, Wilderang U, Verma S, Cowie MR, Solomon SD, McMurray JJV. Wearable Accelerometer-Derived Measures of Physical Activity in Heart Failure: Insights From the DETERMINE trials. J Card Fail. 2025 Apr;31(4):689-703. doi: 10.1016/j.cardfail.2024.10.439. Epub 2024 Nov 26.'}, {'pmid': '39365164', 'type': 'BACKGROUND', 'citation': 'Wettstein R, Sedaghat-Hamedani F, Heinze O, Amr A, Reich C, Betz T, Kayvanpour E, Merzweiler A, Busch C, Mohr I, Friedmann-Bette B, Frey N, Dugas M, Meder B. A Remote Patient Monitoring System With Feedback Mechanisms Using a Smartwatch: Concept, Implementation, and Evaluation Based on the activeDCM Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Nov 22;12:e58441. doi: 10.2196/58441.'}, {'pmid': '39813671', 'type': 'BACKGROUND', 'citation': 'Kitsiou S, Gerber BS, Buchholz SW, Kansal MM, Sun J, Pressler SJ. Patient-Centered mHealth Intervention to Improve Self-Care in Patients With Chronic Heart Failure: Phase 1 Randomized Controlled Trial. J Med Internet Res. 2025 Jan 15;27:e55586. doi: 10.2196/55586.'}, {'pmid': '37498273', 'type': 'BACKGROUND', 'citation': 'Golbus JR, Gosch K, Birmingham MC, Butler J, Lingvay I, Lanfear DE, Abbate A, Kosiborod ML, Damaraju CV, Januzzi JL Jr, Spertus J, Nallamothu BK. Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure. JACC Heart Fail. 2023 Nov;11(11):1521-1530. doi: 10.1016/j.jchf.2023.05.033. Epub 2023 Jul 26.'}, {'pmid': '31638338', 'type': 'BACKGROUND', 'citation': 'Khandwalla RM, Birkeland K, Heywood JT, Steinhubl S, McCague K, Fombu E, Grant D, Riebman JB, Owens RL. Activity Sensors to Evaluate the Effect of Sacubitril/Valsartan on Quality-of-Life in Heart Failure: rational and design of the AWAKE-HF study. ESC Heart Fail. 2019 Dec;6(6):1313-1321. doi: 10.1002/ehf2.12514. Epub 2019 Oct 22.'}, {'pmid': '39387771', 'type': 'BACKGROUND', 'citation': 'Boehmer JP, Cremer S, Abo-Auda WS, Stokes DR, Hadi A, McCann PJ, Burch AE, Bonderman D. Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial. JACC Heart Fail. 2024 Dec;12(12):2011-2022. doi: 10.1016/j.jchf.2024.07.022. Epub 2024 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this research project is to prevent heart failure decompensation through a wearable-based telemonitoring system (smartwatches), with a focus on the development and validation of a multiparametric predictive score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients followed in the heart failure outpatient clinic or previously hospitalized in hospital wards (e.g., cardiology, cardiac surgery, or internal medicine).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Age ≥ 18 years Diagnosis of stable heart failure Cognitively able to participate in the study No significant hearing impairment No significant visual impairment Sufficient ability to read and write in Italian Ownership of a smartphone with internet access\n\nExclusion Criteria Not fully compensated heart failure Lack of a smartphone with internet access'}, 'identificationModule': {'nctId': 'NCT07375251', 'acronym': 'TELEMACO-S', 'briefTitle': 'TELEMACO-S: a Telemonitoring Project in Cardiology and Technology Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero Universitaria di Sassari'}, 'officialTitle': 'TELEMACO-S: a Telemonitoring Project in Cardiology and Technology Transfer Using Telemedicine', 'orgStudyIdInfo': {'id': 'AO SASSARI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with heart failure', 'description': 'Patients with stable heart failure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Sassari', 'state': 'SS', 'country': 'Italy', 'facility': 'AOU Sassari', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valentina Micheluzzi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSN, RN', 'investigatorFullName': 'Valentina Micheluzzi', 'investigatorAffiliation': 'Azienda Ospedaliero Universitaria di Sassari'}}}}