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

NCT07689760 | Not Yet Recruiting

• 1 other identifier: Explain-HF
• Study Type: observational
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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).

Conditions

Heart Failure

Keywords

Heart Failure; Smartwatch; Explainable artificial intelligence

Outcome Measures

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

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

Secondary Outcomes (3)

• Activity patterns

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

• Quality of life (QoL)

  Measured at baseline and at the end of follow-up at 6 months

• Net promotor score (NPS)

  At the end of follow-up at 6 months

Study Arms (1)

Heart failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Deventer Ziekenhuis: collaborator
• Medisch Spectrum Twente: lead
• Saxion University of Applied Sciences: collaborator
• University of Twente: collaborator
• Ziekenhuisgroep Twente: collaborator

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Mark Schuuring, M.D., PhD., FESC, FEACVI, FHFA

CONTACT

0534872105; mark.schuuring@mst.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share