NCT07375251

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

December 23, 2025

Last Update Submit

January 24, 2026

Conditions

Heart Failure Patients

Keywords

Heart Failureacute decompensated heart failurewearable devicestelemonitoring

Outcome Measures

Primary Outcomes (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.

    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)

Study Arms (1)

Patients with heart failure

Patients with stable heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Sassari

Sassari, SS, 07100, Italy

Location

Related Publications (7)

  • 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: 33882601BACKGROUND

  • 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: 39603408BACKGROUND

  • 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: 39365164BACKGROUND

  • 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: 39813671BACKGROUND

  • 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: 37498273BACKGROUND

  • 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: 31638338BACKGROUND

  • 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: 39387771BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSN, RN

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 29, 2026

Study Start

January 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

IT(1)