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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Hybrid heart failure care pathway

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Bart TG Köhlen, MD, MSc; Phone Number: +31883201108; Email: b.kohlen@antoniusziekenhuis.nl

Study Locations

• Netherlands
  • Utrecht
    • Amsterdam, Utrecht, Netherlands, 3435CM
      • Recruiting
      • OLVG
      • Contact: Bart TG Köhlen, MD, MSc; Phone Number: +31652711470; Email: b.kohlen@antoniusziekenhuis.nl
      • Principal Investigator: Petra EJ van Pol, MD
    • Eindhoven, Utrecht, Netherlands, 3435CM
      • Recruiting
      • Catharina Hospital
      • Contact: Bart TG Köhlen, MD, MSc; Phone Number: +31652711470; Email: b.kohlen@antoniusziekenhuis.nl
      • Principal Investigator: Luuk C Otterspoor, MD, PhD
    • Enschede, Utrecht, Netherlands, 3435CM
      • Recruiting
      • Medisch Spectrum Twente
      • Contact: Bart TG Köhlen, MD, MSc; Phone Number: +31652711470; Email: b.kohlen@antoniusziekenhuis.nl
      • Principal Investigator: Mark J Schuuring, MD, PhD
    • Groningen, Utrecht, Netherlands, 3435CM
      • Recruiting
      • Martini Hospital
      • Contact: Bart TG Köhlen, MD, MSc; Phone Number: +31652711470; Email: b.kohlen@antoniusziekenhuis.nl
      • Principal Investigator: Simone CMD Panman, MD, PhD
    • Nieuwegein, Utrecht, Netherlands, 3435CM
      • Recruiting
      • St. Antonius Hospital
      • Contact: Bart TG Köhlen, MD, MSc; Phone Number: +31652711470; Email: b.kohlen@antoniusziekenhuis.nl
      • Principal Investigator: Gerardus PJ van Hout, MD, PhD
    • Nijmegen, Utrecht, Netherlands, 3435CM
      • Recruiting
      • Canisius-Wilhelmina Hospital
      • Contact: Bart TG Köhlen, MD, MSc; Phone Number: +31652711470; Email: b.kohlen@antoniusziekenhuis.nl
      • Principal Investigator: David J Sprenkeler, MD, PhD
    • Rotterdam, Utrecht, Netherlands, 3435CM
      • Recruiting
      • Maasstad Hospital
      • Contact: Bart TG Köhlen, MD, MSc; Phone Number: +31652711470; Email: b.kohlen@antoniusziekenhuis.nl
      • Principal Investigator: Georges C IJff, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days spent out of hospital within one year	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause survival	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	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)	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	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	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

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Gerardus PJ van Hout, MD, PhD, St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: heart failure; remote monitoring; observational cohort study; home telemonitoring systems; hybrid care pathway
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: SDB 2025-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No