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

January 24, 2026 updated by: Valentina Micheluzzi

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • SS
      • Sassari, SS, Italy, 07100
        • AOU Sassari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with heart failure
Patients with stable heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valentina Micheluzzi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AO SASSARI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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