The SMARTER Cardiomyopathy Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorImperial College London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood Sample Collection
Other interventionBlood for DNA and biomarker analysis
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Cardiomyopathies1 intervention
Trial outcomes
Primary outcomes
1
Incidence of genetic variants
Rare and common genetic variants in people with cardiomyopathy
Time frame
5 years2
The incidence of major adverse cardiovascular events over 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)
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov