CardiomyopathiesSMARTER-CMNCT05750147
The SMARTER Cardiomyopathy Study
An observational study of Cardiomyopathies and Hypertrophic Cardiomyopathy, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
Cardiomyopathies are diseases of the heart muscle. Known genetic factors may account for some cardiomyopathy cases but there is still much to understand about the genetic and environmental causes and how the disease progresses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiomyopathies, Hypertrophic Cardiomyopathy, Dilated Cardiomyopathy
- What is being tested?
- Blood Sample Collection
- How many people
- 1,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Mar 2023to 1 Aug 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with a diagnosis of cardiomyopathy, or a family member of cardiomyopathy or a genetic predisposition to cardiomyopathy of any age and any sex.
Who may be able to join
- Adults with the capacity to consent Children with parental/guardian consent Male and Female
- Meeting the following criteria:
- Patients with a confirmed diagnosis of cardiomyopathy or related condition
- Patients with a family member with cardiomyopathy, or a related condition
- Patients with a genetic variant that may predispose to cardiomyopathy, or a related condition
Who cannot join
- Patients without the capacity to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Guys & St Thomas' NHS Foundation Trust
London
smarter-cm@imperial.ac.uk
- Recruiting
Kings College Hospital
London
smarter-cm@imperial.ac.uk
About this study
Official title: Genetics, Imaging and Artificial Intelligence for Precision Care in Cardiomyopathy
Cardiomyopathies are diseases of the heart muscle. Known genetic factors may account for some cardiomyopathy cases but there is still much to understand about the genetic and environmental causes and how the disease progresses.
Finding new ways to diagnose and treat cardiomyopathies could improve the health and well-being of patients with these conditions.
Read more
This study will collect data from individuals with cardiomyopathy or related heart muscle disease, or with a possible genetic predisposition to cardiomyopathy, and follow them over time to observe the progress of their heart and health. This study will collect DNA, blood samples, and detailed clinical \& lifestyle information at the start of the study, and data collected during routine healthcare visits over time.
- learn what causes cardiomyopathy, and therefore how to treat it
- understand why cardiomyopathy progresses differently in different people, to improve the ability to recognise who will benefit from different treatments at different times
The investigators will collaborate with other centres internationally to collect a large of group of participants with similar cardiomyopathies, providing power to identify new pathways that cause disease and ways of predicting which participants are at risk of having more severe disease.
- Being tested
- Blood Sample Collection
- Medical subject headings
- Cardiomyopathies, Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
Blood for DNA and biomarker analysis
| Study group | Role | What they receive |
|---|---|---|
| Cardiomyopathies | Approximately 1000 participants recruited prospectively from participating sites with a diagnosis of cardiomyopathy
Participants will provide biosamples and allow access to medical scans and records for health data collection Receives: Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of genetic variants
Rare and common genetic variants in people with cardiomyopathy
Measured: 5 years
The incidence of major adverse cardiovascular events over 5 years
The incidence of major adverse cardiovascular events over 5 years, defined as:-
- Cardiovascular death
- Major arrhythmic events (ventricular fibrillation, unstable sustained ventricular tachycardia, appropriate implantable cardioverter-defibrillator delivered shock, and aborted sudden cardiac death)
- Major heart failure events (heart transplantation, left ventricular assist device implantation, unplanned heart failure hospitalisation)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Ware, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750147
- Sponsor's protocol ID
- 22IC7783
- Acronym
- SMARTER-CM
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with collaborating researchers in a pseudonymised fashion (removing names, addresses, identifying numbers, DOB etc)
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics, Imaging and Artificial Intelligence for Precision Care in Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05750147
- Acronym / sponsor ID
- SMARTER-CM / 22IC7783
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 1 Mar 2023 (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.
Cardiomyopathies are diseases of the heart muscle. Known genetic factors may account for some cardiomyopathy cases but there is still much to understand about the genetic and environmental causes and how the disease progresses.
Finding new ways to diagnose and treat cardiomyopathies could improve the health and well-being of patients with these conditions.
This study will collect data from individuals with cardiomyopathy or related heart muscle disease, or with a possible genetic predisposition to cardiomyopathy, and follow them over time to observe the progress of their heart and health. This study will collect DNA, blood samples, and detailed clinical \& lifestyle information at the start of the study, and data collected during routine healthcare visits over time.
- learn what causes cardiomyopathy, and therefore how to treat it
- understand why cardiomyopathy progresses differently in different people, to improve the ability to recognise who will benefit from different treatments at different times
The investigators will collaborate with other centres internationally to collect a large of group of participants with similar cardiomyopathies, providing power to identify new pathways that cause disease and ways of predicting which participants are at risk of having more severe disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiomyopathies | – | Other: Blood Sample CollectionApproximately 1000 participants recruited prospectively from participating sites with a diagnosis of cardiomyopathy Participants will provide biosamples and allow access to medical scans and records for health data collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with a diagnosis of cardiomyopathy, or a family member of cardiomyopathy or a genetic predisposition to cardiomyopathy of any age and any sex.
Key inclusion criteria (5 listed)
- Adults with the capacity to consent Children with parental/guardian consent Male and Female
- Patients with a confirmed diagnosis of cardiomyopathy or related condition
- Patients with a family member with cardiomyopathy, or a related condition
- Patients with a genetic variant that may predispose to cardiomyopathy, or a related condition
Key exclusion criteria (1 listed)
- Patients without the capacity to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionBlood for DNA and biomarker analysis | Other | Cardiomyopathies |
Primary outcome
Incidence of genetic variants
Time frame: 5 years
Rare and common genetic variants in people with cardiomyopathy
The incidence of major adverse cardiovascular events over 5 years
Time frame: 5 years
The incidence of major adverse cardiovascular events over 5 years, defined as:- 1. Cardiovascular death 2. Major arrhythmic events (ventricular fibrillation, unstable sustained ventricular tachycardia, appropriate implantable cardioverter-defibrillator delivered shock, and aborted sudden cardiac death) 3. Major heart failure events (heart transplantation, left ventricular assist device implantation, unplanned heart failure hospitalisation)
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 6 Mar 2024.
- Individual participant dataSharing planned: Yes. Data will be shared with collaborating researchers in a pseudonymised fashion (removing names, addresses, identifying numbers, DOB etc)
Related trials for Cardiomyopathies
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Metabolic Disease, Obesity
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Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
Arrhythmogenic Cardiomyopathy
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruitingObservational study
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
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.
James Ware principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Hypertrophic Cardiomyopathy, run by Imperial College London at 2 sites in United Kingdom.
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 5 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: looking for participants now, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Contact Study Coordinator (02073528121, smarter-cm@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of genetic variants (time frame: 5 years). The study lists 2 primary outcomes in all. 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 6 Mar 2024.