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

NCT07680634 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 6000

Last updated 2026-07-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER
  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Gerardus PJ van Hout, MD, PhD · St. Antonius Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2030-12-30
Completion
2031-06-30

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07680634 on ClinicalTrials.gov