NCT07278583

Brief Summary

The aim of this study is to analyze the prognosis and evolution of patients after exclusion of CARDIAUVERGNE, a heart failure telemonitoring system at Clermont-Ferrand's hospital. The patients were included from 1st January 2023 to 31st December 2024 and the monitoring was terminated for end of eligibility according to the french health authority criteria.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress43%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

December 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 1, 2025

Last Update Submit

December 1, 2025

Conditions

Heart Failure

Keywords

heart failuretelemonitoring

Outcome Measures

Primary Outcomes (1)

  • Composite criterion defined by the occurrence within one year following the end of remote monitoring of either cardiovascular death or heart failure worsening (hospitalization or unscheduled visit for heart failure)

    From telemonitoring exclusion up to a year after

Secondary Outcomes (4)

  • Amount of medical appointments

    From telemonitoring exclusion up to a year after

  • Natriuretic peptides evolution

    From inclusion until a year after exclusion

  • Amount of theoretically possible re-included patients during follow up

    From telemonitoring exclusion up to a year after

  • Determination of potential patient profiles more suitable to discontinue remote monitoring

    From inclusion up to a year after telemonitoring exclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients included in CARDIAUVERGNE telemonitoring that have been excluded as they no longer fulfill the inclusion criteria

You may qualify if:

  • adults
  • able to read and understand french
  • included in CARDIAUVERGNE telemonitoring program from 1st january 2023 to 31st december 2024 such as defined by the french health authorithy criteria (heart failure within 12 months or dyspnea at least NYHA 2 associated with NTproBNP of at least 1000pg/mL) and excluded by medical decision as no longer presenting eligibillity criteria

You may not qualify if:

  • Patients leaving telemonitoring for other reasons (choice, death, medical reason, relocation, inobservance)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Related Publications (4)

  • Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.

    PMID: 28785469BACKGROUND

  • Rapport au parlement "évaluation des expérimentations de télésurveillance du programme national étapes" Novembre 2020

    BACKGROUND

  • Haute Autorité Santé. "Télésurveillance médicale du patient insuffisant cardiaque chronique," 2023.

    BACKGROUND

  • Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.

    PMID: 35083827BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Clément RIOCREUX

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)