The SMARTER Cardiomyopathy Study | NCT05750147

Studies
The SMARTER Cardiomyopathy Study

NCT05750147

Sponsor

Imperial College London

Status

Recruiting

Last Update Posted

Mar 6, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Cardiomyopathies
Hypertrophic Cardiomyopathy
Dilated Cardiomyopathy

Interventions

Blood Sample Collection

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Aug 1, 2027Estimated

Completion Date

Aug 1, 2027Estimated

First Submitted Date

Jan 23, 2023

First Submission Date that Met QC Criteria

Feb 20, 2023

First Posted Date

Mar 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Other: Blood Sample Collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Sample Collection	Other	Blood for DNA and biomarker analysis	Cardiomyopathies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of genetic variants	Rare and common genetic variants in people with cardiomyopathy	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)	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients without the capacity to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Coordinator	Contact	02073528121		smarter-cm@imperial.ac.uk

Overall Officials

Name	Affiliation	Role
James Ware	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guys & St Thomas' NHS Foundation Trust	Recruiting	London			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be shared with collaborating researchers in a pseudonymised fashion (removing names, addresses, identifying numbers, DOB etc)

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

During study duration (Aug 2027)

Access Criteria

Provided through secure data transfer mechanisms approved by Imperial College London, following full GDPR (data protection) assessments and collaborating agreements.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009202	Cardiomyopathies
D002312	Cardiomyopathy, Hypertrophic
D002311	Cardiomyopathy, Dilated

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001020	Aortic Stenosis, Subvalvular
D001024	Aortic Valve Stenosis

Browse Leaves

Not provided

Browse Branches

Not provided