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Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure (HARMONY-HF)

1 juillet 2026 mis à jour par: B.T.G. Köhlen, St. Antonius Hospital

Heart failure is a long-term condition in which the heart cannot pump blood as well as it should. People with heart failure often need to be admitted to hospital when their symptoms suddenly get worse, which affects their quality of life and places a heavy burden on the healthcare system.

In recent years, hospitals have started using home telemonitoring, in which patients measure values such as their weight, blood pressure, heart rate, and symptoms at home every day. These measurements are sent to a Medical Service Center (MSC), who can step in quickly when early warning signs appear - often before the patient feels seriously unwell.

The HARMONY-HF study looks at how well this hybrid care pathway works in everyday practice. The researchers will compare heart failure patients who take part in the home telemonitoring programme with patients who receive usual care without telemonitoring, across seven hospitals in the Netherlands. Because all care is part of routine treatment, patients are not asked to do anything extra for the study; the researchers use information that is already collected during normal care.

The main goal is to find out whether patients in the telemonitoring programme spend more days at home and out of the hospital. The study also looks at survival, hospital admissions, quality of life, and the use of recommended heart failure medication. The findings will help determine whether this approach should be offered more widely.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

The HARMONY-HF study is a real-world, multicentre, observational cohort study with both retrospective and prospective components.

Type d'étude

Observationnel

Inscription (Estimé)

6000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Pays-Bas
    • Utrecht
      • Amsterdam, Utrecht, Pays-Bas, 3435CM
        • Recrutement
        • OLVG
        • Contact:
        • Chercheur principal:
          • Petra EJ van Pol, MD
      • Eindhoven, Utrecht, Pays-Bas, 3435CM
        • Recrutement
        • Catharina Hospital
        • Contact:
        • Chercheur principal:
          • Luuk C Otterspoor, MD, PhD
      • Enschede, Utrecht, Pays-Bas, 3435CM
        • Recrutement
        • Medisch Spectrum Twente
        • Contact:
        • Chercheur principal:
          • Mark J Schuuring, MD, PhD
      • Groningen, Utrecht, Pays-Bas, 3435CM
        • Recrutement
        • Martini Hospital
        • Contact:
        • Chercheur principal:
          • Simone CMD Panman, MD, PhD
      • Nieuwegein, Utrecht, Pays-Bas, 3435CM
        • Recrutement
        • St. Antonius Hospital
        • Contact:
        • Chercheur principal:
          • Gerardus PJ van Hout, MD, PhD
      • Nijmegen, Utrecht, Pays-Bas, 3435CM
        • Recrutement
        • Canisius-Wilhelmina Hospital
        • Contact:
        • Chercheur principal:
          • David J Sprenkeler, MD, PhD
      • Rotterdam, Utrecht, Pays-Bas, 3435CM
        • Recrutement
        • Maasstad Hospital
        • Contact:
        • Chercheur principal:
          • Georges C IJff, MD, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The entire HF population treated at the participating hospitals will be included in the analysis, except for those patients who have formally objected to the use of their data for scientific research

La description

Inclusion Criteria:

  • Adults (at least 18 years or older)
  • Diagnosed with heart failure according the prevailling ESC guideline
  • Treatment at the outpatient clinic at one of the seven participating hospitals
  • Sufficient digital literacy and adequate Dutch language proficiency by the patient or throught the informal caregiver.

Exclusion Criteria:

  • Inability or unwillingness to participate in home telemonitoring
  • Patients with end-stage heart failure or other terminal conditions

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Conventional heart failure care pathway
The control cohort comprises all HF patients treated at the same hospitals during the identical inclusion period who do not participate in the hybrid pathway and therefore do not receive home telemonitoring
Autre: Hybrid heart failure care pathway
The intervention cohort comprises all adult patients (aged 18 years or older) with an established diagnosis of HF, made in accordance with the prevailing European Society of Cardiology guidelines and irrespective of HF phenotype, who are enrolled in the hybrid care pathway with home telemonitoring since the start of implementation of the program in May 2023. Patients are included in the hybrid care pathwat if they are treated at the outpatient clinic, and are sufficiently digitally literate and Dutch-speaking, either themselves or through an informal caregiver.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of days spent out of hospital within one year
Délai: From enrollment to the end of follow-up at 400 days after inclusion
For each patient, follow-up time is calculated from the inclusion date until the earliest of the following: the end of the 400-day analysis period, death, or the last known date of contact (i.e., loss to follow-up). The number of days without hospitalisation is derived by subtracting the number of unplanned in-hospital days from each patient's accumulated person-time. By censoring follow-up at the date of death, person-time reflects only the period during which a patient was actually observed and at risk, thereby accounting for the competing risk of mortality. Although the primary outcome concerns the first year of follow-up, the analysis period is defined as the first 400 days after the inclusion date rather than exactly 365 days. In routine clinical practice, it is not always possible for a patient to attend an outpatient contact precisely 365 days after the start date. A modest margin is incorporated around the one-year mark, thereby maximising the proportion of complete follow-up.
From enrollment to the end of follow-up at 400 days after inclusion

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
All-cause survival
Délai: From enrollment to the end of follow-up at 400 days after inclusion
Probability of survival free from all-cause death, estimated using the Kaplan-Meier method, reported as the percentage of participants alive at 400 days.
From enrollment to the end of follow-up at 400 days after inclusion
HF-related survival
Délai: From enrollment to the end of follow-up at 400 days after inclusion
Probability of heart failure related death, estimated using the Kaplan-Meier method, reported as the percentage of participants alive at 400 days.
From enrollment to the end of follow-up at 400 days after inclusion
Health-related quality of life (KCCQ-12)
Délai: Baseline, 3 months, 6 months and 12 months
Based on the Kansas City Cardiomyopathy Questionnaire, units on a scale 0-100 (higher is better)
Baseline, 3 months, 6 months and 12 months
Healthcare utalisation and associated costs
Délai: From enrollment to the end of follow-up at 400 days after inclusion
An economic evaluation will be performed as a cost-effectiveness analysis from a healthcare payer perspective and will be based on a discrete event simulation (DES) model. This event- and time-based structure is particularly suited for HF, in which the risk of clinical worsening/decompensation fluctuates over time and is influenced by patient-specific characteristics, and it allows for heterogeneity of the real-world population captured in this study. Patient-level data from both cohorts will be used to inform the model's input parameters. Costs will comprise those of regular HF care, home telemonitoring, clinical events and outpatient contacts, and pharmaceutical treatment, valued using the Dutch costing manual in accordance with the guidelines for economic evaluations. The primary economic outcome will be the incremental cost-effectiveness ratio (ICER).
From enrollment to the end of follow-up at 400 days after inclusion
Guideline-Directed Medical Treatment (GMDT) scores
Délai: Baseline, 6 weeks, 3 months, 6 months and 12 months
The adequacy of pharmacological treatment is quantified using the GDMT-score, calculated according to the method described by Man et al: the sum dose ratios of the foundational HF therapies, each expressed as the prescribed dose relative to the guideline-recommended target dose, supplemented by additional components (0-1) for switching to an ARNI and for adequate iron status. The iron status will be reported as separate item. Units on a scale 0-5 (higher is better) for prescribed medication; percentage of patient with adequate iron status (0-100; higher is better)
Baseline, 6 weeks, 3 months, 6 months and 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

St. Antonius Hospital

Collaborateurs

ZonMw: The Netherlands Organisation for Health Research and Development

Les enquêteurs

  • Chercheur principal: Gerardus PJ van Hout, MD, PhD, St. Antonius Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2023

Achèvement primaire (Estimé)

30 décembre 2030

Achèvement de l'étude (Estimé)

1 juin 2031

Dates d'inscription aux études

Première soumission

25 juin 2026

Première soumission répondant aux critères de contrôle qualité

1 juillet 2026

Première publication (Réel)

2 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SDB 2025-019

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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