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

1 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Osservativo

Iscrizione (Stimato)

6000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of days spent out of hospital within one year
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause survival
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

St. Antonius Hospital

Collaboratori

ZonMw: The Netherlands Organisation for Health Research and Development

Investigatori

  • Investigatore principale: Gerardus PJ van Hout, MD, PhD, St. Antonius Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2023

Completamento primario (Stimato)

30 dicembre 2030

Completamento dello studio (Stimato)

1 giugno 2031

Date di iscrizione allo studio

Primo inviato

25 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 luglio 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SDB 2025-019

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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