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

1. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Anslået)

6000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of days spent out of hospital within one year
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause survival
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

St. Antonius Hospital

Samarbejdspartnere

ZonMw: The Netherlands Organisation for Health Research and Development

Efterforskere

  • Ledende efterforsker: Gerardus PJ van Hout, MD, PhD, St. Antonius Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2023

Primær færdiggørelse (Anslået)

30. december 2030

Studieafslutning (Anslået)

1. juni 2031

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SDB 2025-019

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Hjertefejl

Kliniske forsøg med Hybrid heart failure care pathway

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