Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06024759 |
Other study ID # |
13529 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 1, 2023 |
Est. completion date |
August 1, 2033 |
Study information
Verified date |
October 2023 |
Source |
Lawson Health Research Institute |
Contact |
Dr. Habib Khan |
Phone |
519-663-3746 |
Email |
habib.khan[@]lhsc.on.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The goal of this study is to learn more about the risk factors associated with left
ventricular non-compaction (LVNC) and the predictors of adverse outcomes associated with
LVNC. The main questions this study aims to answer are as follows.
- Are there any genetic mutations that impact the risk of LVNC patients developing
ventricular arrhythmias?
- Does LV myocardial strain increase risk stratification in the LVNC population with or
without genetic mutations?
- What are some of the determinants that cause LV dysfunction in LVNC?
- What are other risk stratifiers (ex. premature ventricular contraction (PVC) burden on
Holter, non-sustained ventricular tachycardia (NSVT) on stress test) that lead to an
outcome of ICD implantation?
Participants will have their medical records accessed annually for a span of ten years,
either prospectively or retrospectively depending on whether they are being actively followed
by physicians at the Inherited Arrhythmia Clinic or not, to evaluate LVNC progression over
time. This data will be stored in a large clinical registry with the London Heart Rhythm
Program at the London Health Sciences Centre, University Hospital Campus.
Description:
Left ventricular noncompaction (LVNC) is a congenital cardiomyopathy in which the left
ventricle (LV) of the heart does not develop properly due to impaired myocardial compaction.
In utero, cardiac muscle is initially sponge-like, eventually becoming smooth and firm
through a process termed compaction. Specifically, in LVNC, impairment of compaction leads to
the distal portion of the LV myocardium being thicker and more sponge-like than normal.
Hypertrabeculation of the myocardium, where pieces of the heart muscle extend into the LV,
result in blood-filled trabeculae and intertrabecular recesses forming within the inner
endocardial wall. Collectively, this impairs the LV's ability to pump oxygenated blood
throughout the body.
Although various strategies are used to manage LVNC once diagnosed, the severity of
comorbidities caused by LVNC, including but not limited to atrial fibrillation, embolism, or
stroke, warrant further investigation into the risk factors, etiology and management of LVNC.
Furthermore, patients with a definitive diagnosis of LVNC are at an elevated risk of
experiencing sudden cardiac arrest (SCA) or sudden cardiac death (SCD). However, little is
known about risk stratification with regards to LVNC that can result in SCA or SCD, further
highlighting the need for greater analysis of the risk factors implicated in this disease
state.
Ultimately, a holistic understanding of the risk factors of LVNC and subsequent morbidities
it causes is needed to help improve the diagnosis, treatment and management of patients with
LVNC. Hence, the goal of this study is to evaluate the risk factors and mutations associated
with cardiovascular events in patients with a confirmed diagnosis of LVNC who have preserved
cardiac function.
This study aims to further investigate the risk factors associated with the onset and
development of LVNC. Specifically, data will be collected from retrospective and prospective
patients. The retrospective cohort consists of patients who are no longer being actively
followed by physicians at the Inherited Arrhythmia Clinic at the London Health Sciences
Centre, University Hospital Campus, whose data will be collected annually from their medical
records from the past ten years. The prospective cohort consists of patients who are being
actively followed by physicians at the Inherited Arrhythmia Clinic who, once consented and
enrolled, will have their charts accessed annually for the next ten years.