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Enrolling by Invitation

NCT Number: NCT07345338

Mainstreaming Genetic Testing for Non-Ischemic Cardiomyopathy in Western Canada

Heart muscle disorders are a common cause of heart failure: a life-threatening condition that can cause dangerous abnormal heart rhythms (arrhythmia) and a buildup of fluid in the body (edema). In British Columbia (BC) and Alberta, patients with heart failure are cared for in specialized Heart Function Clinics (HFC). Providers in these clinics rapidly diagnose and treat heart failure because early treatment prevents death and disability. In some situations, particularly in young people, heart failure is caused by abnormalities in the genetic blueprint of the heart muscle - this is present at birth and passed down within families (i.e. hereditary). The investigators can diagnose this genetic abnormality by a simple blood or saliva test, which allows for better treatment of patients and diagnosis of family members to protect against heart failure and death. In BC and Alberta, people suspected of having this form of heart failure must be referred to highly specialized programs to receive genetic testing, as these healthcare systems currently do not offer genetic testing through HFCs. However, HFC providers are unaware or discouraged to refer patients because of very long waitlists of these programs. In this study, the investigators want to educate, enable, and empower HFC cardiologists to order genetic testing for heart failure. If such an intervention demonstrates success in this study, patients will no longer have to wait for up to 3 years to see a genetic specialist. Patients will be diagnosed and treated earlier, and their family members who might be in danger of having the condition can be informed more quickly. The investigators aim to leverage this study to encourage healthcare leadership to facilitate more timely access to genetic testing by showing the positive impact on health outcomes.

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Key information

Conditions

Nonischemic Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dilated Cardiomyopathy (DCM) Genetic Diseases, Inborn Heart Diseases Laminopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre Cardiac Function Clinic, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Clinical eligibility for non-ischemic cardiomyopathy/dilated cardiomyopathy (NICM/DCM) genetic testing, per existing clinical criteria in each respective province a. BC sites - presence of NICM/DCM with at least one of the following: i. Family history of NICM/DCM ii. Evidence of conduction disease iii. Arrhythmia (Ventricular or atrial) iv. Unexplained cardiomyopathy under 70 years v. Suggestive syndrome(s)

Alberta sites - Left ventricular ejection fraction of less than 50% and any degree of left or right ventricular dilation

Exclusion criteria

  • Previously known genetic result that explains NICM/DCM
  • Under age 18 years
  • Declines genetic testing

Treatment and study plan

Health service delivery change

Other

Genetic testing for patients with unexplained non-ischemic cardiomyopathy offered directly by cardiologists in Heart Function Clinics

Primary outcomes

  1. Uptake of genetic testing for non-ischemic cardiomyopathy (NICM)

    Time frame: Through 12 months after first participant enrollment

    Proportion of eligible patients who complete clinical genetic testing for non-ischemic cardiomyopathy (NICM) following referral from a Heart Function Clinic.

  2. Time to genotypic diagnosis

    Time frame: Up to 12 months after consent for genetic testing is provided.

    Time (in days) from the date informed consent for genetic testing is signed to the date genetic test results are returned.

Secondary outcomes

  1. Proportion of participants with a change in clinical management following genetic test results

    Time frame: Up to 12 months after return of genetic test results

    Change in clinical management is defined as the initiation, discontinuation, or modification of at least one of the following, documented in the medical record after return of genetic test results:

    • Heart failure pharmacotherapy
    • Cardiac device therapy (e.g., implantable cardioverter-defibrillator [ICD], cardiac resynchronization therapy [CRT]) or transplantation
    • Referral to specialized services (e.g., inherited cardiomyopathy clinic, genetic counseling)
    • Pregnancy-related guidance or referral
    • Family cascade testing or screening recommendations

  2. Patient-reported satisfaction, knowledge, and decision quality related to genetic testing

    Time frame: At 12 months after first participant enrollment

    Patient-reported outcomes assessed using a study-specific survey administered after receipt of information about genetic testing and discussion with a heart specialist. The survey includes:

    Knowledge items assessed using true/false/"I don't know" questions related to inherited heart disease and genetic testing

    Attitudinal items assessing views on genetic testing using 5-point Likert scales, where higher scores indicate more favorable views

    Experience and process items assessed using yes/no questions (e.g., whether sufficient time was provided)

    Decision satisfaction and decision quality items assessed using 5-point Likert scales ranging from strongly disagree (1) to strongly agree (5), with higher scores indicating greater satisfaction and alignment with personal values

  3. Proportion of participants with a change to family screening recommendations following genetic test results

    Time frame: Up to 12 months after return of genetic test results

    Change in family screening recommendations is defined as any new, modified, or discontinued recommendation for screening of first- or second-degree relatives documented in the participant's medical record after return of genetic test results. This includes, but is not limited to:

    • Initiation of cascade genetic testing for relatives
    • Recommendations for cardiac imaging or surveillance in family members
    • Changes in age of screening initiation or screening interval
    • Determination that no family screening is recommended

Sponsors and collaborators

Lead sponsor

Thomas Roston

Other

Collaborators

  • Genome Alberta
  • Genome British Columbia
  • University of Calgary

Registry information

Official study title

Mainstreaming Genetic Testing for Non-Ischemic Cardiomyopathy in Western Canada: A Family-Centered and Genome-First Approach to a Common and Life-Threatening Cardiomyopathy

Acronym: HOGI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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