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Non-ischemic Cardiomyopathy Registry, Biobank and Imaging Data Repository

ConditionNon-ischemic Cardiomyopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMontreal Heart Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Primary valvular disease including moderate to severe aortic stenosis and moderate to severe mitral stenosis, primary severe mitral regurgitation (secondary valvular disease such as mitral regurgitation/tricuspid regurgitation are not exclusion criteria)

Other distinct entities: Amyloid heart disease, Chagas, Takotsubo, sarcoidosis, hemochromatosis related cardiomyopathy, HIV related cardiomyopathy are excluded

Trial 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

Trial design

Design model

Family-based

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Time to first sustained ventricular arrhythmia

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

Time frame
5 years
2

Time to first life-threatening ventricular arrhythmia

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

Time frame
5 years
3

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

Time frame
5 years
4

Atrial fibrillation and thromboembolic events:

Atrial fibrillation Stroke or systemic embolism

Time frame
5 years

Secondary outcomes

1

Number of hospitalization or emergency visit for worsening heart failure

Time frame
5 years
2

Rate of end-Stage HF

Composite of heart transplant, mechanical cardiac support implantation, or cardiovascular death.

Time frame
5 years
3

Number of clinical HF

Composite of hospitalization or emergency room visit for HF (admission primarily for HF and worsening HF requiring intensification of HF treatment), new prescription of loop diuretic or LVEF decline to \<40% with change ≥ 10% from baseline (TTE or CMR).

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montreal Heart Institute

Lead sponsor

Source ClinicalTrials.gov
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