Prognostic Impact of Diabetes and Weight Variability in Telemonitored Heart Failure (DM-HF-Tele)
24. April 2026 aktualisiert von: Satelia
Impact of Diabetes, Short-term Weight Variability, Heart Failure Etiologies and Other Comorbidities on Survival in a National Telemonitored Heart Failure Cohort
This observational cohort study evaluates the prognostic impact of diabetes, comorbidity burden, and short-term weight variability among adults with chronic heart failure enrolled in a nationwide remote patient monitoring program in France.
Patients were enrolled between September 3 2018 and April 3 2024 as part of routine heart failure care.
Baseline demographic, clinical, and treatment data, along with weight measurements collected through telemonitoring, were analyzed.
The study aims to assess associations between diabetes status, multimorbidity, and weight variability with survival outcomes using retrospective data from the program database.
No study-mandated interventions were performed.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This retrospective, multicenter observational cohort study was conducted using data from a nationwide heart failure remote patient monitoring program in France. The program supports routine clinical management of patients with chronic heart failure through digital symptom and weight monitoring, automated alerts, and coordination with healthcare providers.
The study includes adult patients enrolled between September 2018 and April 2024. Clinical characteristics recorded at enrollment were extracted from the program database, including demographics, heart failure severity indicators, comorbid conditions, and treatment information. Repeated weight measurements obtained during telemonitoring were used to calculate short-term weight variability as a marker of dynamic physiological status.
The primary objective is to evaluate the association between diabetes and survival in patients with chronic heart failure. Secondary objectives include assessment of the impact of overall comorbidity burden and short-term weight variability on survival, as well as exploration of interactions between diabetes, age, and multimorbidity.
All treatments and monitoring were part of routine care. No interventions were assigned by the study protocol. Statistical analyses include survival modeling and multivariable adjustment to identify independent predictors of outcomes.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
16556
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Bordeaux, Frankreich, 33000
- Satelia
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
he study population consists of adults with chronic heart failure in France who were enrolled in a nationwide remote patient monitoring program between September 2018 and April 2024 as part of routine clinical care.
Patients entered the program following hospitalization for heart failure or in the ambulatory setting based on clinical criteria consistent with heart failure management.
The cohort includes individuals with and without diabetes and represents patients managed across a range of healthcare settings, including university hospitals, non-university hospitals, and outpatient practices.
Beschreibung
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of chronic heart failure
- Enrolment in the national heart failure remote monitoring program between September 3, 2018, and April 3, 2024
- Availability of baseline clinical data including diabetes status
Exclusion Criteria:
- Missing baseline information on diabetes status
- Missing follow-up data for survival status
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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Heart Failure Telemonitoring Cohort
Adults with chronic heart failure enrolled in a nationwide remote patient monitoring program in France between September 2018 and April 2024.
Clinical characteristics at enrolment and weight measurements collected during routine telemonitoring were analyzed to evaluate associations between diabetes, comorbidity burden, weight variability, and survival outcomes in routine care.
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Presence or absence of diabetes mellitus recorded at enrolment as part of routine clinical assessment.
Number of chronic comorbid conditions recorded at enrollment, used as a measure of multimorbidity.
Short-term variability in body weight calculated from repeated weight measurements collected during routine telemonitoring, used as a marker of dynamic physiological status.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Association Between Diabetes Status and All-Cause Mortality
Zeitfenster: From enrolment up to 3 years of follow-up
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Relationship between the presence of diabetes mellitus at enrolment and subsequent risk of death, evaluated using multivariable survival analysis.
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From enrolment up to 3 years of follow-up
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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All-Cause Mortality
Zeitfenster: From enrolment in the remote monitoring program up to 3 years of follow-up
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Time from enrolment to death from any cause, assessed using follow-up data collected during routine care within the remote monitoring program.
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From enrolment in the remote monitoring program up to 3 years of follow-up
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Association Between Comorbidity Burden and All-Cause Mortality
Zeitfenster: From enrolment up to 3 years of follow-up
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Association between the number of chronic comorbid conditions at enrolment and risk of death during follow-up.
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From enrolment up to 3 years of follow-up
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Association Between Short-Term Weight Variability and All-Cause Mortality
Zeitfenster: From enrolment up to 3 years of follow-up
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Relationship between short-term variability in body weight measured during telemonitoring and subsequent risk of death
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From enrolment up to 3 years of follow-up
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Paul Valensi, Assistance Publique - Hôpitaux de Paris
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- Seferovic PM, Petrie MC, Filippatos GS, Anker SD, Rosano G, Bauersachs J, Paulus WJ, Komajda M, Cosentino F, de Boer RA, Farmakis D, Doehner W, Lambrinou E, Lopatin Y, Piepoli MF, Theodorakis MJ, Wiggers H, Lekakis J, Mebazaa A, Mamas MA, Tschope C, Hoes AW, Seferovic JP, Logue J, McDonagh T, Riley JP, Milinkovic I, Polovina M, van Veldhuisen DJ, Lainscak M, Maggioni AP, Ruschitzka F, McMurray JJV. Type 2 diabetes mellitus and heart failure: a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2018 May;20(5):853-872. doi: 10.1002/ejhf.1170. Epub 2018 Mar 8.
- Cosentino F, Grant PJ, Aboyans V, Bailey CJ, Ceriello A, Delgado V, Federici M, Filippatos G, Grobbee DE, Hansen TB, Huikuri HV, Johansson I, Juni P, Lettino M, Marx N, Mellbin LG, Ostgren CJ, Rocca B, Roffi M, Sattar N, Seferovic PM, Sousa-Uva M, Valensi P, Wheeler DC; ESC Scientific Document Group. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020 Jan 7;41(2):255-323. doi: 10.1093/eurheartj/ehz486. No abstract available.
- Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
- Valensi P, Henry P, Boccara F, Cosson E, Prevost G, Emmerich J, Ernande L, Marcadet D, Mousseaux E, Rouzet F, Sultan A, Ferrieres J, Verges B, Van Belle E. Risk stratification and screening for coronary artery disease in asymptomatic patients with diabetes mellitus: Position paper of the French Society of Cardiology and the French-speaking Society of Diabetology. Diabetes Metab. 2021 Mar;47(2):101185. doi: 10.1016/j.diabet.2020.08.002. Epub 2020 Aug 23. No abstract available.
- Valensi P, Paries J, Brulport-Cerisier V, Torremocha F, Sachs RN, Vanzetto G, Cosson E, Lormeau B, Attali JR, Marechaud R, Estour B, Halimi S. Predictive value of silent myocardial ischemia for cardiac events in diabetic patients: influence of age in a French multicenter study. Diabetes Care. 2005 Nov;28(11):2722-7. doi: 10.2337/diacare.28.11.2722.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
3. September 2018
Primärer Abschluss (Tatsächlich)
3. April 2024
Studienabschluss (Tatsächlich)
3. April 2024
Studienanmeldedaten
Zuerst eingereicht
24. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. April 2026
Zuerst gepostet (Tatsächlich)
1. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DM-HF-Tele
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Individual participant data collected for this study are derived from a national telemonitoring program and contain sensitive health information.
Data sharing is restricted due to patient privacy protections and applicable European data protection regulations (GDPR).
Access to de-identified data may be considered upon reasonable request and subject to appropriate data protection agreements and regulatory approval.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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