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OpenTrials
Enrolling by Invitation

NCT Number: NCT07689760

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medisch Spectrum Twente

Enschede, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult HF patients
  • NYHA class II, or NYHA III
  • Recent 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Activity patterns

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

    Activity patterns measured with the smartwatch

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Medisch Spectrum Twente

Other

Collaborators

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

Registry information

Acronym: ExplAIn-HF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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