Predictors of Risk in Left Ventricular Non-Compaction

NCT06024759 | Recruiting

• 1 other identifier: 13529
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Left Ventricular Noncompaction

Keywords

LVNC; Left Ventricular Non-Compaction

Outcome Measures

Primary Outcomes (1)

• Develop a large clinical registry linked with the Inherited Arrhythmia Clinic

  The Inherited Arrhythmia Clinic is a subdivision of the London Heart Rhythm Program at University Hospital, London Health Sciences Centre. As such, data will not go offsite but will simply be stored in a local REDCap database.

  Up to 10 years

Secondary Outcomes (3)

• Identification of genetic mutations linked to LVNC

  Up to 10 years

• Identification of determinants that cause LV dysfunction

  Up to 10 years

• Identification of factors that lead to ICD implantation

  Up to 10 years

Study Arms (2)

Retrospective Cohort

Individuals in this group were previously seen by physicians at the Inherited Arrhythmia Clinic at University Hospital, London Health Sciences Centre, yet are no longer being actively followed here anymore. These patients will have their data retrospectively obtained annually, ten years into the past, to collect data on key variables providing insight on LVNC progression over time.

Prospective Cohort

Patients being actively followed up by physicians at the Inherited Arrhythmia Clinic will be approached either in person or via e-mail for consent and enrollment into this study. These patients will have their medical charts accessed annually to collect data on key variables providing insight on LVNC progression over time.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in this study have a confirmed diagnosis of LVNC. Specifically, those in the prospective cohort are being actively followed up by physicians at the Inherited Arrhythmia Clinic whereas those in the retrospective cohort are no longer being actively followed up.

You may qualify if:

• Patients must meet the following criteria in order to be included in the study.
• Have a confirmed diagnosis of LVNC (between 2010-2020 for patients in the retrospective cohort only)
• Be over 18 years of age

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A5A5, Canada

RECRUITING

Biospecimen

Retention: NONE RETAINED

Genetic testing

Central Study Contacts

Dr. Habib Khan

CONTACT

519-663-3746; habib.khan@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 1, 2033
• Study Completion (Estimated): August 1, 2033
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

CA (1)