Heart FailureExplAIn-HFNCT07689760
Explainable AI for Predicting Hospital Admissions in Heart Failure: ExplAIn-HF
An observational study of Heart Failure, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial summary
The goal of this observational study is to develop and validate an XAI based model that predicts HF events and identifies modifiable con-tributing factors, and to evaluate the added value of integrating high frequency smartwatch data compared to usual care in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 95 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2026to Dec 2027
- 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: Patients will be selected after HF hospitalization at three hospitals: Medisch Spectrum Twente (MST), Hospital Group Twente (ZGT), and Deventer hospital.
Who may be able to join
- Adult HF patients
- NYHA class II, or NYHA III
- Rehospitalization for HF
- Usual care with active participation in the telemonitoring program "Zorg Bij Jou" (ZBJ)
- Possession of an iPhone 11 or newer and compatible with the study apps
Who cannot join
- Lack of digital literacy or inability to use the device
- Not capable to sign consent
- Referral to hospice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to develop and validate an XAI based model that predicts HF events and identifies modifiable con-tributing factors, and to evaluate the added value of integrating high frequency smartwatch data compared to usual care in patients with heart failure. The main objectives of the study are:
- To develop and validate an XAI based model that predicts HF events and identifies modifiable contributing factors, and to evaluate the added value of integrating high frequency smartwatch data compared to usual care. In the Netherlands usual care includes remote monitoring of heartrate, blood pressure, weight and symptoms.
- To include insights of the smartwatch into activity patterns, impact on quality of life (KCCQ-12), and patient satisfaction with net promoter score (NPS).
Participants will wear a smartwatch for six months and perform an I-lead ecg with the smartwatch weekly.
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Smartwatch, Explainable artificial intelligence
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure (HF) event
HF event is defined as:
- Increase in diuretic treatment
- Increase in NYHA class
- Hospitalization caused by HF
- Death caused by HF
Measured: From enrollment to the end of follow-up at 6 months
Secondary outcomes (3)
Activity patterns
Activity patterns measured with the smartwatch
Measured: From enrollment to the end of follow-up at 6 months
Quality of life (QoL)
QoL measured with Kansas City Cardiomyopathy Questionnaire-12
Measured: Measured at baseline and at the end of follow-up at 6 months. The Kansas City Cardiomyopathy Questionnaire is scored on a scale of 0 to 100; higher scores indicate better health.
Net promotor score
Net promotor score measures how likely patients are to recommend this technology to others. This score ranges from 0 to 10. Higher values indicate a greater likelihood of recommending to others.
Measured: At the end of follow-up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start13 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- Saxion University of Applied Sciences, Deventer Ziekenhuis, University of Twente, Ziekenhuisgroep Twente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689760
- Sponsor's protocol ID
- Explain-HF
- Acronym
- ExplAIn-HF
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal medical data
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explainable AI for Predicting Hospital Admissions in Heart Failure: ExplAIn-HF
- ClinicalTrials.gov ID
- NCT07689760
- Acronym / sponsor ID
- ExplAIn-HF / Explain-HF
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Smartwatch, Explainable artificial intelligence
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Collaborators
- Saxion University of Applied Sciences, Deventer Ziekenhuis, University of Twente, Ziekenhuisgroep Twente
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 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.
The goal of this observational study is to develop and validate an XAI based model that predicts HF events and identifies modifiable con-tributing factors, and to evaluate the added value of integrating high frequency smartwatch data compared to usual care in patients with heart failure. The main objectives of the study are:
- To develop and validate an XAI based model that predicts HF events and identifies modifiable contributing factors, and to evaluate the added value of integrating high frequency smartwatch data compared to usual care. In the Netherlands usual care includes remote monitoring of heartrate, blood pressure, weight and symptoms.
- To include insights of the smartwatch into activity patterns, impact on quality of life (KCCQ-12), and patient satisfaction with net promoter score (NPS).
Participants will wear a smartwatch for six months and perform an I-lead ecg with the smartwatch weekly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected after HF hospitalization at three hospitals: Medisch Spectrum Twente (MST), Hospital Group Twente (ZGT), and Deventer hospital.
Key inclusion criteria (5 listed)
- Adult HF patients
- NYHA class II, or NYHA III
- Rehospitalization for HF
- Usual care with active participation in the telemonitoring program "Zorg Bij Jou" (ZBJ)
- Possession of an iPhone 11 or newer and compatible with the study apps
Key exclusion criteria (3 listed)
- Lack of digital literacy or inability to use the device
- Not capable to sign consent
- Referral to hospice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart failure (HF) event
Time frame: From enrollment to the end of follow-up at 6 months
HF event is defined as: * Increase in diuretic treatment * Increase in NYHA class * Hospitalization caused by HF * Death caused by HF
3 secondary outcomes
Activity patterns
Time frame: From enrollment to the end of follow-up at 6 months
Quality of life (QoL)
Time frame: Measured at baseline and at the end of follow-up at 6 months. The Kansas City Cardiomyopathy Questionnaire is scored on a scale of 0 to 100; higher scores indicate better health.
Net promotor score
Time frame: At the end of follow-up at 6 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 18 Sep 2026.
- Individual participant dataSharing planned: No. Personal medical data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Medisch Spectrum Twente at 1 site 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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure (HF) event (time frame: From enrollment to the end of follow-up at 6 months). 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 18 Sep 2026.