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

September 17, 2026 updated by: Medisch Spectrum Twente

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Enschede, Netherlands
        • Medisch Spectrum Twente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Lack of digital literacy or inability to use the device
  • Not capable to sign consent
  • Referral to hospice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Heart failure patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of follow-up at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity patterns
Time Frame: From enrollment to the end of follow-up at 6 months
Activity patterns measured with the smartwatch
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.
QoL measured with Kansas City Cardiomyopathy Questionnaire-12
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
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.
At the end of follow-up at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medisch Spectrum Twente

Collaborators

Deventer Ziekenhuis
Ziekenhuisgroep Twente
University of Twente
Saxion University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Explain-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Personal medical data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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