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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07689760

Acronym

ExplAIn-HF

Enrollment

Registered

2026-07-08

Start date

2026-07-01

Completion date

2027-12-01

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Smartwatch, Explainable artificial intelligence

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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Heart failure (HF) event	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

Measure	Time frame	Description
Activity patterns	From enrollment to the end of follow-up at 6 months	Activity patterns measured with the smartwatch
Quality of life (QoL)	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
Net promotor score	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.

Countries

Netherlands

Outcome results