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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HCM - Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere university

Tampere, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HCM or carrying. mutation for HCM

Exclusion criteria

Treatment and study plan

Primary outcomes

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

Time frame: from patient records until the end of 2026

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

Other outcomes

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

Time frame: January 2024 to December 2026

All cardiac medication will be recorded and the reason this has changed during the analysis timepoints.

Incidence of other diseases will be included in the analysis e.g. stroke, myocardial infarction, atrial fibrillation, depression, changes in vascular status (mainly blood pressure) The number of hospital visits is recorded and the reason for those

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

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

Registry information

Acronym: SMASH-HCM

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2028
First posted: Aug 20, 2025
Registry last updated: Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting