Hypertrophic Cardiomyopathy Registry, Biobank, and Imaging Data Repository

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

HiRO-HCM is a multicenter, observational program that prospectively enrolls individuals with hypertrophic cardiomyopathy or those carrying related gene variants. The study collects baseline clinical data, genetic results, imaging studies (including echocardiography and cardiac MRI), and biomarkers, with data stored in a secure, de-identified repository. Goals include identifying markers of adverse outcomes, developing risk prediction models, and clarifying the genetic architecture of HCM. The study is led by the Montreal Heart Institute with collaboration from CIHR and multiple Canadian centers. Participation is contingent on informed consent and can be withdrawn at any time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients with (1) AND/OR (2)

1. Clinical diagnosis of HCM, defined as

   1. maximal LVWT ≥15mm, or
   2. maximal LVWT ≥13mm, in presence of a diagnosis of first degree relative with HCM, or
   3. septal wall thickness with z-score \>2 in a child

   AND/OR
2. Carrier of a pathogenic or likely pathogenic genetic variant in a sarcomeric gene (ACTC1, FHOD3, MYBPC3, MYH7, MYL2, MYL3, TNNI3, TNNT2, TPM1). Variant classification should be performed by a certified diagnostic laboratory according to the American College of Medical Genetics and Genomics (ACMG) guidelines.

Exclusion Criteria:

1. Clinical or molecular diagnosis of Noonan syndrome or other Rasopathies
2. Clinical or molecular diagnosis of metabolic disease associated with cardiomyopathy, such as Pompe (GAA), Fabry (GLA), Danon (LAMP2), AMP-kinase (PRKAG2), and carnitine disorders
3. Clinical diagnosis of a neuromuscular disease associated with cardiomyopathy, such as Friedrich's ataxia
4. Clinical diagnosis of cardiac amyloidosis with or without the presence of genetic variants in TTR
5. Clinical or molecular diagnosis of mitochondrial cardiomyopathy
6. Diagnosis of HCM \>65 years old AND absence of pathogenic or likely pathogenic variant in a sarcomeric gene (as defined in inclusion criterion 1B above)
7. History of myocardial infarction
8. History of moderate or severe aortic stenosis
9. History of congenital heart defects requiring percutaneous or surgical correction
10. History of severe hypertension defined as a systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>110 mmHg AND absence of pathogenic or likely pathogenic variant in a sarcomeric gene (as defined in inclusion criterion 1B above)
11. Refusal to provide informed consent or to provide a biospecimen for DNA analysis
12. No possibility to upload transthoracic echocardiogram or cardiac magnetic resonance imaging for core lab interpretation

Where it's running

• Mazankowski Alberta Heart Institute
  Edmonton, Alberta, Canada Recruiting
• UBC St. Paul's Hospital
  Vancouver, British Columbia, Canada Recruiting
• Vancouver Island Health Authority
  Victoria, British Columbia, Canada Recruiting
• St. Boniface Hospital
  Winnipeg, Manitoba, Canada Recruiting
• IWK Health Centre
  Halifax, Nova Scotia, Canada Recruiting
• Queen Elizabeth II Health Sciences Centre
  Halifax, Nova Scotia, Canada Recruiting

Study contacts

• Principal investigator: Rafik Tadros, Dr. — Montreal Heart Institute
• Study coordinator: Svenja Koslowski
• Email: hiro-hcm@icm-mhi.org
• Phone: 514-376-3330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.