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Heart Failure PatientsTELEMACO-SNCT07375251

TELEMACO-S: a Telemonitoring Project in Cardiology and Technology Transfer

An observational study of Heart Failure Patients, run by Valentina Micheluzzi at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure Patients
How many people
250 participants
Where
1 siteItaly
Study dates
1 Jan 2025to Mar 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients followed in the heart failure outpatient clinic or previously hospitalized in hospital wards (e.g., cardiology, cardiac surgery, or internal medicine).

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

  • AOU Sassari

    Sassari, SS, 07100

Other trials in Italy

About this study

Official title: TELEMACO-S: a Telemonitoring Project in Cardiology and Technology Transfer Using Telemedicine

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.

Keywords
Heart Failure, acute decompensated heart failure, wearable devices, telemonitoring
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07375251
Study groupRoleWhat they receive
Patients with heart failurePatients with stable heart failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in the number of hospitalizations for acute heart failure decompensation

    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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2026
  2. Study start1 Jan 2025
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07375251
Sponsor's protocol ID
AO SASSARI
Acronym
TELEMACO-S
Status last verified
Jan 2026
First submitted
23 Dec 2025
Last updated
29 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 39387771

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure Patients, run by Valentina Micheluzzi at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

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?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07375251, which also lists 7 linked publications.

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 29 Jan 2026.

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