TELEMACO-S: a Telemonitoring Project in Cardiology and Technology Transfer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
TELEMACO-S: a Telemonitoring Project in Cardiology and Technology Transfer Using Telemedicine
Overview
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.
Primary outcome measures
- Reduction in the number of hospitalizations for acute heart failure decompensation [Time frame: 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)]
Eligibility criteria
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
Exclusion Criteria Not fully compensated heart failure Lack of a smartphone with internet access
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- AOU Sassari — Sassari
Publications
- 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 33882601
- 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 39603408
- 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 39365164
- 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 39813671
- 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 37498273
- 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 31638338
- 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. PMID 39387771
Identifiers
NCT: NCT07375251 · AO SASSARI