Mainstreaming Genetic Testing for Non-Ischemic Cardiomyopathy in Western Canada (HOGI)

Thomas Roston

Status: Not yet enrolling

Conditions: Dilated Cardiomyopathy (DCM); Nonischemic Cardiomyopathy

Treatments: Other: Health service delivery change

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07345338

H25-02075

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older
2. 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

1. Previously known genetic result that explains NICM/DCM
2. Under age 18 years
3. Declines genetic testing

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Mainstreamed Genetic Testing through Heart Function Clinics

Experimental group

Description:

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

Treatment:

Other: Health service delivery change

Traditional Referral Pathway for Genetic Testing

No Intervention group

Description:

Traditional referral pathway to a specialized cardiac genetics clinic