Mainstreaming Genetic Testing for Non-Ischemic Cardiomyopathy in Western Canada

NCT07345338 | Not Yet Recruiting

• 1 other identifier: H25-02075
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Nonischemic Cardiomyopathy; Dilated Cardiomyopathy (DCM)

Outcome Measures

Primary Outcomes (2)

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

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

  Through 12 months after first participant enrollment

• Time to genotypic diagnosis

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

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

Secondary Outcomes (3)

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

  Up to 12 months after return of genetic test results

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

  At 12 months after first participant enrollment

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

  Up to 12 months after return of genetic test results

Study Arms (2)

Mainstreamed Genetic Testing through Heart Function Clinics

EXPERIMENTAL

Mainstreamed genetic testing offered directly by the Heart Function Clinic cardiologist with video-based genetic counselling tools

Other: Health service delivery change

Traditional Referral Pathway for Genetic Testing

NO INTERVENTION

Traditional referral pathway to a specialized cardiac genetics clinic

Interventions

Health service delivery change OTHER

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

Mainstreamed Genetic Testing through Heart Function Clinics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Roston: lead
• Genome British Columbia: collaborator
• Genome Alberta: collaborator
• University of Calgary: collaborator

Study Sites (4)

Peter Lougheed Centre Cardiac Function Clinic

Calgary, Alberta, T1Y6J4, Canada

Location

Foothills Medical Centre Cardiac Function Clinic

Calgary, Alberta, T2N2T9, Canada

Location

Vancouver General Hospital Cardiac Function Clinic

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital Heart Function Clinic

Vancouver, British Columbia, V6Z1Y6, Canada

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thomas Roston, MD/PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Moller-Hansen

CONTACT

604-875-4111; ashley.mollerhansen@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cluster randomized crossover trial with 4 sites (each province will have an intervention and control site; allocations will remain in place for the first 6 months - after 6 months, the sites switch allocations and begin enrolling new participants under these allocations).

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)