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Stratification, Management, and Guidance of Hypertrophic Cardiomyopathy Patients Using Hybrid Digital Twin Solutions

Stratification, Management, and Guidance of Hypertrophic Cardiomyopathy Patients Using Hybrid Digital Twin Solutions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07131371
Acronym
SMASH-HCM
Enrollment
2500
Registered
2025-08-20
Start date
2024-01-15
Completion date
2028-12-31
Last updated
2026-08-17

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

Conditions

HCM - Hypertrophic Cardiomyopathy

Keywords

HCM, digital twin, AI, in silico modelling, iPSC-derived cardiomyocytes

Brief summary

The goal of SMASH-HCM is to develop a digital twin or virtual model of the heart and vascular system with sympathetic nerve control that integrates multi-scale and multi-organ spatiotemporal biophysical data from a multitude of sources. SMASH-HCM's digital twin powered platform will dramatically improve hypertrophic cardiomyopathy (HCM) patient stratification and disease management through stepwise deep phenotyping integrated in clinical and patient-guided workflows.

Detailed description

The aim of this SMASH-HCM study is with available well-characterized clinical data and existing iPSC derived cardiomyocyte data from HCM patients to find better predictors of worse outcomes i.e. potentially lethal arrhythmias, heart failure, sudden cardiac arrest in HCM patients. Additionally with artificial intelligence (AI) to find markers of good outcome so that we could focus more on those who would potentially benefit more from the intense follow up. Additionally our aim is to create a digital twin by collecting all possible clinical data from the HCM patients and also from currently healthy mutation carriers to be able to predicts the clinical out in more personal way and also toddling treatment strategies in more personal manner.

Interventions

None listed

Sponsors

University of Rennes 2
CollaboratorOTHER
University of Florence
CollaboratorOTHER
Tampere University
Lead SponsorOTHER
University of Bologna
CollaboratorOTHER
Rennes University Hospital
CollaboratorOTHER
University of Milan
CollaboratorOTHER
University College Dublin
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
Medtronic Bakken Research
CollaboratorINDUSTRY
Pharmatics Limited
CollaboratorUNKNOWN
University of Oxford
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HCM or carrying. mutation for HCM

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Clinical characteristics of patients with severe arrhythmias, heart failure, sudden death or implantation of ICD for Digital Twin creationfrom patient records until the end of 2026The presence of arrhythmias will be obtained from 24 h Holter recordings, stress exercise test, monitor recording if in the hospital and if found in clinical patient records. Heart failure data if obtained from ultrasound records, clinical observations and elevated natriuretic peptide levels in the serum. Data about sudden deaths are obtained from patient records. Requirements of ICD implantations are obtained from patient records

Countries

Finland

Contacts

STUDY_DIRECTORJari Hyttinen, Professor

Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026