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Enrolling by invitation NCT07689760

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

Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Heart failure (HF) event [Time frame: From enrollment to the end of follow-up at 6 months]
Secondary outcome measures (3)
  • Activity patterns [Time frame: 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.]
  • Net promotor score [Time frame: At the end of follow-up at 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Medisch Spectrum Twente — Enschede

Identifiers

NCT: NCT07689760 · Explain-HF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗