ClinicalTrials.gg
Enrolling by invitationNCT07689760ExplAIn-HFUpdated Sep 18, 2026

Explainable AI for Predicting Hospital Admissions in Heart Failure: ExplAIn-HF

An observational study in Heart Failure, sponsored by Medisch Spectrum Twente. Enrolling by invitation at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Medisch Spectrum Twente · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
95
Ages
18 Years and older
Sex
All
01

Study 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. The main objectives of the study are:

  1. 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.
  2. 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Heart Failure
  • Smartwatch
  • Explainable artificial intelligence
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 95 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medisch Spectrum Twente is the lead sponsor of 23 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be selected after HF hospitalization at three hospitals: Medisch Spectrum Twente (MST), Hospital Group Twente (ZGT), and Deventer hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult HF patients
  • 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

Exclusion criteria

Exclusion Criteria:

  • Lack of digital literacy or inability to use the device
  • Not capable to sign consent
  • Referral to hospice
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
95 participants (estimated)
Patient registry
No

Groups and cohorts

  • Heart failure patients
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From enrollment to the end of follow-up at 6 months

Secondary outcomes

  1. Activity patterns

    Activity patterns measured with the smartwatch

    Time frame: From enrollment to the end of follow-up at 6 months

  2. Quality of life (QoL)

    QoL measured with Kansas City Cardiomyopathy Questionnaire-12

    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.

  3. 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.

    Time frame: At the end of follow-up at 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Personal medical data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07689760
Lead sponsor
Medisch Spectrum Twente
Collaborators
Saxion University of Applied Sciences, Deventer Ziekenhuis, University of Twente, Ziekenhuisgroep Twente
Responsible party
Sponsor
First posted
Jul 8, 2026
Start date
Jul 13, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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