Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure

NCT07680634 | Recruiting

• 1 other identifier: SDB 2025-019
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Heart Failure

Keywords

heart failure; home telemonitoring systems; remote monitoring; hybrid care pathway; observational cohort study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• All-cause survival

  From enrollment to the end of follow-up at 400 days after inclusion

• HF-related survival

  From enrollment to the end of follow-up at 400 days after inclusion

• Health-related quality of life (KCCQ-12)

  Baseline, 3 months, 6 months and 12 months

• Healthcare utalisation and associated costs

  From enrollment to the end of follow-up at 400 days after inclusion

• Guideline-Directed Medical Treatment (GMDT) scores

  Baseline, 6 weeks, 3 months, 6 months and 12 months

Study Arms (1)

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

Interventions

Hybrid heart failure care pathway OTHER

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.

Conventional heart failure care pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Antonius Hospital: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (7)

OLVG

Amsterdam, Utrecht, 3435CM, Netherlands

RECRUITING

Catharina Hospital

Eindhoven, Utrecht, 3435CM, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, Utrecht, 3435CM, Netherlands

RECRUITING

Martini Hospital

Groningen, Utrecht, 3435CM, Netherlands

RECRUITING

St. Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

RECRUITING

Canisius-Wilhelmina Hospital

Nijmegen, Utrecht, 3435CM, Netherlands

RECRUITING

Maasstad Hospital

Rotterdam, Utrecht, 3435CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gerardus PJ van Hout, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart TG Köhlen, MD, MSc

CONTACT

+31883201108; b.kohlen@antoniusziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 2, 2026
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: July 2, 2026

Record last verified: 2026-07

Locations

NL (7)