Explainable AI for Predicting Hospital Admissions in Hear... | NCT07689760

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

NCT07689760

Sponsor

Medisch Spectrum Twente

Status

Not yet recruiting

Last Update Posted

Jul 8, 2026Actual

Enrollment

95Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jul 1, 2026

First Submission Date that Met QC Criteria

Jul 1, 2026

First Posted Date

Jul 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 8, 2026Actual

Name	Class
Saxion University of Applied Sciences	OTHER
Deventer Ziekenhuis	OTHER
University of Twente	OTHER
Ziekenhuisgroep Twente

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.
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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

95Estimated

Label	Type	Description	Intervention Names
Heart failure patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Activity patterns	Activity patterns measured with the smartwatch	From enrollment to the end of follow-up at 6 months
Quality of life (QoL)	QoL measured with KCCQ-12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients will be selected after HF hospitalization at three hospitals: Medisch Spectrum Twente (MST), Hospital Group Twente (ZGT), and Deventer hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mark Schuuring, M.D., PhD., FESC, FEACVI, FHFA	Contact	0534872105		mark.schuuring@mst.nl

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Personal medical data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided