Left Ventricular NoncompactionNCT06024759
Predictors of Risk in Left Ventricular Non-Compaction
An observational study of Left Ventricular Noncompaction, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Noncompaction
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 1 Aug 2033
- How long will I take part?
- 10 Years
- 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 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients are ineligible to participate in this study if they do not meet one or more of the inclusion criterion or if they have any other cardiomyopathy aside from LVNC that is linked to a genetic mutation they carry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A5A5
Dr. Habib Khan, 519-663-3746, habib.khan@lhsc.on.ca
About this study
Official title: Long Term Registry of Patients With Left Ventricular Non-Compaction and Predictors of Adverse Outcomes
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.
Read the detailed 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.
- Conditions
- Left Ventricular Noncompaction
- Keywords
- LVNC, Left Ventricular Non-Compaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 years
Secondary outcomes (3)
Identification of genetic mutations linked to LVNC
Enrolled patient's will have their genetic test results thoroughly reviewed (if applicable) to better understand their involvement in the onset and progression of LVNC.
Measured: Up to 10 years
Identification of determinants that cause LV dysfunction
Enrolled patient's will have their medical charts accessed to identify factors contributing to LV dysfunction in patients with LVNC.
Measured: Up to 10 years
Identification of factors that lead to ICD implantation
Enrolled patient's will have their medical charts accessed to identify risk factors that lead to ICD implantation (if applicable) in patients with LVNC.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Aug 2033 (estimated)
- Study completion1 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular NoncompactionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024759
- Sponsor's protocol ID
- 13529
- Status last verified
- Oct 2023
- First submitted
- 31 Jul 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Registry of Patients With Left Ventricular Non-Compaction and Predictors of Adverse Outcomes
- ClinicalTrials.gov ID
- NCT06024759
- Acronym / sponsor ID
- 13529
- Conditions
- Left Ventricular Noncompaction
- Keywords
- LVNC, Left Ventricular Non-Compaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Aug 2033 (estimated)
- Study completion
- 1 Aug 2033 (estimated)
- First posted
- 6 Sep 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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients are ineligible to participate in this study if they do not meet one or more of the inclusion criterion or if they have any other cardiomyopathy aside from LVNC that is linked to a genetic mutation they carry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a large clinical registry linked with the Inherited Arrhythmia Clinic
Time frame: Up to 10 years
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.
3 secondary outcomes
Identification of genetic mutations linked to LVNC
Time frame: Up to 10 years
Identification of determinants that cause LV dysfunction
Time frame: Up to 10 years
Identification of factors that lead to ICD implantation
Time frame: Up to 10 years
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 1 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Noncompaction, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Dr. Habib Khan (519-663-3746, habib.khan@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a large clinical registry linked with the Inherited Arrhythmia Clinic (time frame: Up to 10 years). 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 1 Nov 2023.