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

NCT07131371 | Active Not Recruiting

• 1 other identifier: 101137115
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

HCM - Hypertrophic Cardiomyopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical characteristics of patients with severe arrhythmias, heart failure, sudden death or implantation of ICD for Digital Twin creation

  The 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

  from patient records until the end of 2026

Other Outcomes (1)

• Other clinical characteristics of patients with severe outcomes due to HCM compared to those with mild disease for the creation of SMASH-HCM algorithm.

  January 2024 to December 2026

Study Arms (1)

HCM patients from Florence Italy, Rennes, France, and Tampere Finland

HCM patients in follow up

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

HCM patients followed in the clinical sites in this study: Florence Italy, Rennes France and Tampere Finland

You may qualify if:

• HCM or carrying. mutation for HCM

Sponsors & Collaborators

• Tampere University: lead
• University of Bologna: collaborator
• Universita Degli Studi di Firenze: collaborator
• Rennes University Hospital: collaborator
• University of Milan: collaborator
• University College Dublin: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Medtronic Bakken Research: collaborator
• Pharmatics Limited: collaborator
• University of Oxford: collaborator
• University of Rennes 2: collaborator

Study Sites (1)

Tampere university

Tampere, Finland

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Jari Hyttinen, Professor

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 20, 2025
• Study Start: January 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1.1.2025-31.12.2028
• Access Criteria: The databank is simply a file-sharing app using Nextcloud, with user access controls and monitoring

Locations

FI (1)