Evaluation of Heart Failure Telemonitoring Eligibility Criteria
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. 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
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Eligibility Criteria for Heart Failure Telemonitoring : Analysis of CARDIAUVERGNE's Cohort
Overview
CARDIAUVERGNE is a heart failure telemonitoring system at Clermont-Ferrand's hospital. The aim of this study is to analyze the prognosis and evolution of patients after exclusion of telemonitoring. 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.
Detailed description
After an episode of heart failure, patients have been included in a telemonitoring program in order to reduce rehospitalizations for heart failure and improve follow-up. On a daily basis, the patients weigh themselves on connected scales which enables a team of dedicated nurses to follow them closely. If need be they can call the patient, ask for a blood exam and adapt their prescription. Indeed, if remote support is insufficient, patients can be hospitalized prematurely and so decrease the duration of hospital care.
The inclusion criteria correspond to either an episode of heart failure in the last 12 months or dyspnea at least New York Heart Association (NYHA) 2 with NT-proBNP over 1000pg/mL.
The follow up is renewed every 6 months. Patients are excluded from monitoring when criteria are no longer fulfilled. As these characteristics have been chosen empirically, our aim is to see if patients no longer presenting these standards have indeed a low chance of bad evolution.
Information is gathered from their medical record at inclusion, exclusion and 1 year after exclusion. A short phone call is made after 1 year of exclusion, to appreciate their evolution and gather information concerning their symptoms, treatments ...
Primary outcome measures
- 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) [Time frame: From telemonitoring exclusion up to a year after]
Secondary outcome measures (4)
- Amount of medical appointments [Time frame: From telemonitoring exclusion up to a year after]
- Natriuretic peptides, NTproBNP, evolution [Time frame: From inclusion until a year after exclusion]
- Number of patients that could theoretically be re-included during follow up [Time frame: From telemonitoring exclusion up to a year after]
- Determination of potential patient profiles more suitable to discontinue remote monitoring [Time frame: From inclusion up to a year after telemonitoring exclusion]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients leaving telemonitoring for other reasons (choice, death, medical reason, relocation, inobservance)
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
- Cohort
Study locations
France · 1 center
- CHU Clermont-Ferrand — Clermont-Ferrand
Publications
- 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 28785469
- Rapport au parlement "évaluation des expérimentations de télésurveillance du programme national étapes" Novembre 2020
- Haute Autorité Santé. "Télésurveillance médicale du patient insuffisant cardiaque chronique," 2023.
- 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 PMID 35083827
Identifiers
NCT: NCT07278583 · RNI 2025 RIOCREUX