Heart FailureHARMONY-HFNCT07680634
Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure
An observational study of Heart Failure, run by St. Antonius Hospital at 7 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Hybrid heart failure care pathway
- How many people
- 6,000 participants
- Where
- 7 sitesNetherlands
- Study dates
- 1 May 2023to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Inability or unwillingness to participate in home telemonitoring
- Patients with end-stage heart failure or other terminal conditions
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Recruiting
OLVG
Amsterdam, Utrecht, 3435CM
Bart TG Köhlen, MD, MSc, +31652711470, b.kohlen@antoniusziekenhuis.nl
Petra EJ van Pol, MD
- Recruiting
Catharina Hospital
Eindhoven, Utrecht, 3435CM
Bart TG Köhlen, MD, MSc, +31652711470, b.kohlen@antoniusziekenhuis.nl
Luuk C Otterspoor, MD, PhD
- Recruiting
Medisch Spectrum Twente
Enschede, Utrecht, 3435CM
Bart TG Köhlen, MD, MSc, +31652711470, b.kohlen@antoniusziekenhuis.nl
Mark J Schuuring, MD, PhD
- Recruiting
Martini Hospital
Groningen, Utrecht, 3435CM
Bart TG Köhlen, MD, MSc, +31652711470, b.kohlen@antoniusziekenhuis.nl
Simone CMD Panman, MD, PhD
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3435CM
Bart TG Köhlen, MD, MSc, +31652711470, b.kohlen@antoniusziekenhuis.nl
Gerardus PJ van Hout, MD, PhD
- Recruiting
Canisius-Wilhelmina Hospital
Nijmegen, Utrecht, 3435CM
Bart TG Köhlen, MD, MSc, +31652711470, b.kohlen@antoniusziekenhuis.nl
David J Sprenkeler, MD, PhD
- Recruiting
Maasstad Hospital
Rotterdam, Utrecht, 3435CM
Bart TG Köhlen, MD, MSc, +31652711470, b.kohlen@antoniusziekenhuis.nl
Georges C IJff, MD, PhD
About this study
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.
Read more
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.
Read the detailed description
The HARMONY-HF study is a real-world, multicentre, observational cohort study with both retrospective and prospective components.
- Conditions
- Heart Failure
- Being tested
- Hybrid heart failure care pathway
- Keywords
- heart failure, home telemonitoring systems, remote monitoring, hybrid care pathway, observational cohort study
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid heart failure care pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Hybrid heart failure care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of follow-up at 400 days after inclusion
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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)
Measured: Baseline, 6 weeks, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 May 2023
- Primary completion30 Dec 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, B.T.G. Köhlen, St. Antonius Hospital
- Investigators
- Gerardus PJ van Hout, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680634
- Sponsor's protocol ID
- SDB 2025-019
- Acronym
- HARMONY-HF
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure
- ClinicalTrials.gov ID
- NCT07680634
- Acronym / sponsor ID
- HARMONY-HF / SDB 2025-019
- Conditions
- Heart Failure
- Keywords
- heart failure, home telemonitoring systems, remote monitoring, hybrid care pathway, observational cohort study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The HARMONY-HF study is a real-world, multicentre, observational cohort study with both retrospective and prospective components.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional heart failure care pathway | – | Other: Hybrid heart failure care pathwayThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability or unwillingness to participate in home telemonitoring
- Patients with end-stage heart failure or other terminal conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid heart failure care pathwayThe 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. | Other | Conventional heart failure care pathway |
Primary outcome
Number of days spent out of hospital within one year
Time frame: 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.
5 secondary outcomes
All-cause survival
Time frame: From enrollment to the end of follow-up at 400 days after inclusion
HF-related survival
Time frame: From enrollment to the end of follow-up at 400 days after inclusion
Health-related quality of life (KCCQ-12)
Time frame: Baseline, 3 months, 6 months and 12 months
Healthcare utalisation and associated costs
Time frame: From enrollment to the end of follow-up at 400 days after inclusion
Guideline-Directed Medical Treatment (GMDT) scores
Time frame: Baseline, 6 weeks, 3 months, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerardus PJ van Hout, MD, PhD principal investigator
St. Antonius Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by St. Antonius Hospital at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bart TG Köhlen, MD, MSc (+31883201108, b.kohlen@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days spent out of hospital within one year (time frame: From enrollment to the end of follow-up at 400 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.