Genetic Testing for Heart Failure

(HOGI Trial)

Not yet recruiting at 3 trial locations
AM
Overseen ByAshley Moller-Hansen
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Thomas Roston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

TR

Thomas Roston, MD/PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for patients in Western Canada with heart failure, specifically non-ischemic cardiomyopathy. It's aimed at those who are currently being treated in Heart Function Clinics and could benefit from genetic testing to identify hereditary causes of their condition.

Inclusion Criteria

I have a heart condition with a family history or symptoms like irregular heartbeats.
I am eligible for genetic testing for NICM/DCM based on my location's criteria.
I am 18 years old or older.
See 1 more

Exclusion Criteria

I have a genetic result explaining my heart condition.
I am under 18 years old.
I have chosen not to undergo genetic testing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Testing and Counseling

Participants undergo genetic testing and receive video-based genetic counseling

Up to 12 months
Multiple visits as needed for testing and counseling

Follow-up

Participants are monitored for changes in clinical management and family screening recommendations

Up to 12 months after return of genetic test results

What Are the Treatments Tested in This Trial?

Interventions

  • Mainstreaming Genetic Testing

Trial Overview

The study is testing a change in health service delivery by empowering HFC cardiologists to order genetic tests directly. This aims to speed up diagnosis and treatment for patients, avoiding long waits to see genetic specialists.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mainstreamed Genetic Testing through Heart Function ClinicsExperimental Treatment1 Intervention
Group II: Traditional Referral Pathway for Genetic TestingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Roston

Lead Sponsor

Genome British Columbia

Industry Sponsor

Trials
13
Recruited
223,000+

Genome Alberta

Collaborator

Trials
4
Recruited
13,700+

University of Calgary

Collaborator

Trials
827
Recruited
902,000+