Non-ischemic Cardiomyopathy Registry, Biobank and Imaging Data Repository

NCT07110818 | Recruiting

• 1 other identifier: MP-33-2024-3373
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of CaNICM is to create a central database that includes a biobank and an imaging data repository for patients with non-ischemic cardiomyopathy (NICM), as well as for at-risk family members. This includes people who carry rare genetic variants linked to NICM but do not show symptoms, and first-degree relatives. The specific goals of this database and biobank are to: Enhance investigators' ability to predict the risk of heart rhythm disorders in patients with NICM. Optimize the timing and approach for screening family members who may carry the disease - determining who to test, when, and how. Find the best ways to treat family members early to prevent or slow the disease. Future Phase - Phase 2 Goal: 4\. Prospectively evaluate how well this risk prediction model works in real-life clinical settings, and compare it to the current approach, which is often based on a single risk factor.

Conditions

Non-ischemic Cardiomyopathy

Keywords

genetic; echocardiography; cardiac magnetic resonance imaging; biomarker; risk prediction model

Outcome Measures

Primary Outcomes (4)

• Time to first sustained ventricular arrhythmia

  Spontaneous sustained VT ICD intervention (shock or antitachycardia pacing) Aborted sudden cardiac arrest (SCA) Sudden cardiac death (SCD)

  5 years

• Time to first life-threatening ventricular arrhythmia

  defined as VT with a cycle length ≤ 240 ms (≥250 bpm)

  5 years

• Time to (aborted) sudden cardiac death in non-ICD carriers

  5 years

• Atrial fibrillation and thromboembolic events:

  Atrial fibrillation Stroke or systemic embolism

  5 years

Secondary Outcomes (3)

• Number of hospitalization or emergency visit for worsening heart failure

  5 years

• Rate of end-Stage HF

  5 years

• Number of clinical HF

  5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with NICM (non-schemic cardiomyopathy) as well as at-risk family members including unaffected carriers of rare genetic variants in genes causing NICM and first degree family members

You may qualify if:

• LVEF \<50% and/or
• LVEF 50-55% with presence of clinically significant late gadolinium enhancement or LV dilatation and being carrier of a non ischemic cardiomyopathy causing gene (Pathogenic or likely pathogenic variant in a Clingen moderate or definite gene)

You may not qualify if:

• A significant other cause of decreased LVEF such as:
• Coronary artery stenosis (Significant lesion on proximal Left anterior descending or Left main, or ≥2 main branches with stenosis. Significant lesion is defined as \>70% of any artery or \>50% for the left main artery) or prior history of type 1 myocardial infarction
• Significant congenital heart disease requiring intervention
• Other distinct entities: Amyloid heart disease, Chagas, Takotsubo, sarcoidosis, hemochromatosis related cardiomyopathy, HIV related cardiomyopathy are excluded
• Substances/therapies induced cardiomyopathy only if they are deemed to be the sole explanation for the cardiomyopathy (at the discretion of the enrolling cardiologist)
• Clear history of burned out hypertrophic cardiomyopathy
• Already had a transplantation at time of first CMR
• Refusal to provide informed consent
• Additional remarks:
• Patients aged \> 70 years of age at first contact with a cardiologist regarding the cardiomyopathy will be limited to maximum 10% of the total enrolled patients by center.
• Patients with risk factors (for example, chemotherapy, radiotherapy, alcohol…) for cardiomyopathy are not excluded unless they are deemed to completely account for the phenotype per the treating physician.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA isolated from blood or saliva

Central Study Contacts

Melissa Lavallée

CONTACT

1-514-376-3330; melissa.lavallee@icm-mhi.org

Caroline Girard

CONTACT

1-514-376-3330; caroline.girard@icm-mhi.org

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: August 8, 2025
• Study Start: April 2, 2024
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: August 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)