HCM - Hypertrophic CardiomyopathySMASH-HCMNCT07131371
Stratification, Management, and Guidance of Hypertrophic Cardiomyopathy Patients Using Hybrid Digital Twin Solutions
An observational study of HCM - Hypertrophic Cardiomyopathy, run by Tampere University at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCM - Hypertrophic Cardiomyopathy
- How many people
- 2,500 participants
- Where
- 1 siteFinland
- Study dates
- 15 Jan 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCM patients followed in the clinical sites in this study: Florence Italy, Rennes France and Tampere Finland
Who may be able to join
- HCM or carrying. mutation for HCM
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HCM - Hypertrophic Cardiomyopathy
- Keywords
- HCM, digital twin, AI, in silico modelling, iPSC-derived cardiomyocytes
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCM patients from Florence Italy, Rennes, France, and Tampere Finland | HCM patients in follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from patient records until the end of 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start15 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCM - Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna, Rennes University Hospital, University of Milan, University College Dublin, Universitätsklinikum Hamburg-Eppendorf, Medtronic Bakken Research, Pharmatics Limited, University of Oxford, University of Rennes 2, University of Florence
- Responsible party
- Principal investigator, Katriina Aalto-Setälä, Tampere University
- Investigators
- Jari Hyttinen, Professor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131371
- Sponsor's protocol ID
- 101137115
- Acronym
- SMASH-HCM
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical data (ECG, ultra sound, cardiac MR, cardiac biomarkers, gene mutations, additional diseases) found in patient files will be shared with this study consortium with different AI groups specializing in each specific clinical record.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratification, Management, and Guidance of Hypertrophic Cardiomyopathy Patients Using Hybrid Digital Twin Solutions
- ClinicalTrials.gov ID
- NCT07131371
- Acronym / sponsor ID
- SMASH-HCM / 101137115
- Conditions
- HCM - Hypertrophic Cardiomyopathy
- Keywords
- HCM, digital twin, AI, in silico modelling, iPSC-derived cardiomyocytes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- University of Bologna, Rennes University Hospital, University of Milan, University College Dublin, Universitätsklinikum Hamburg-Eppendorf, Medtronic Bakken Research, Pharmatics Limited, University of Oxford, University of Rennes 2, University of Florence
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCM patients from Florence Italy, Rennes, France, and Tampere Finland | – | –HCM patients in follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCM patients followed in the clinical sites in this study: Florence Italy, Rennes France and Tampere Finland
Key inclusion criteria (1 listed)
- HCM or carrying. mutation for HCM
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Clinical data (ECG, ultra sound, cardiac MR, cardiac biomarkers, gene mutations, additional diseases) found in patient files will be shared with this study consortium with different AI groups specializing in each specific clinical record.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari Hyttinen, Professor study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCM - Hypertrophic Cardiomyopathy, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.