Genetic Testing for Heart Failure

(HOGI Trial)

Not yet recruiting at 3 trial locations

Overseen By Ashley Moller-Hansen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Roston

Disqualifiers: Known genetic result, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a quicker method for offering genetic testing for heart failure, often caused by inherited heart muscle disorders. By enabling cardiologists in Heart Function Clinics to order these tests directly, the trial aims to speed up diagnosis and treatment, while also informing at-risk family members sooner. The study tests two approaches: direct genetic testing at clinics and the traditional route through specialized programs. Potential participants include those with heart failure related to non-ischemic cardiomyopathy (a heart muscle disease not caused by blocked arteries) and a family history or related heart issues like arrhythmia. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative approaches in genetic testing for heart failure.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that mainstreaming genetic testing is safe for heart failure patients?

Research shows that genetic testing is generally well-accepted in heart failure services. One study found that 5 out of 17 people with a strong family history of heart issues had genetic risks identified. This indicates that the testing is safe and useful for spotting potential heart problems in families. Genetic testing is commonly used to diagnose and manage heart conditions, helping doctors predict and lower risks for patients. Studies have not identified any serious safety concerns with genetic testing in heart failure clinics. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new approach to genetic testing for heart failure because it streamlines the process, making it more accessible and quicker for patients. Unlike the traditional referral method, which involves a lengthy process to a specialized genetics clinic, this approach integrates genetic testing directly into heart function clinics. This method uses video-based genetic counseling tools, allowing cardiologists to offer immediate and personalized insights. By simplifying and speeding up the genetic testing process, this approach could lead to faster diagnosis and more tailored treatments for patients with heart failure.

What evidence suggests that mainstreaming genetic testing is effective for heart failure?

Studies have shown that genetic testing plays a crucial role in diagnosing heart muscle problems that can lead to heart failure. This trial will compare two approaches: Mainstreamed Genetic Testing through Heart Function Clinics and the Traditional Referral Pathway for Genetic Testing. Research suggests that increasing the availability of genetic testing in clinics can enhance care by quickly identifying genetic causes of heart failure. This enables faster treatment and informs family members who might also be at risk. Evidence shows that genetic testing identifies heart muscle disorders in about 16% of patients, with the success rate rising to 30% for those with a family history. Allowing heart doctors to order these tests directly, as in the Mainstreamed Genetic Testing arm, helps patients avoid long wait times and receive necessary care sooner. ^{2 3 4 6 7}

Who Is on the Research Team?

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.

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?

Group I: Mainstreamed Genetic Testing through Heart Function Clinics Experimental Treatment 1 Intervention

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

Group II: Traditional Referral Pathway for Genetic Testing Active Control 1 Intervention

Traditional referral pathway to a specialized cardiac genetics clinic

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07345338?lastUpdPost=2020-01-10_

Mainstreaming Genetic Testing for Non-Ischemic ...

In this study, the investigators want to educate, enable, and empower HFC cardiologists to order genetic testing for heart failure. If such ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/CIR.0000000000001385

Genetic and Genomic Testing in Cardiovascular Disease

Genetic testing plays a central role in the diagnosis, risk prediction and mitigation, and clinical management of individuals with both ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12352198/

Process for mainstreaming genetic cascade testing into ...

Advances in clinical genomics have raised the importance of integrating genomic medicine across healthcare systems, including primary care.

4.

medrxiv.org

medrxiv.org/content/10.1101/2025.09.29.25336936v1.full.pdf

Cardiovascular genetic counseling is associated with ...

These data thus suggest that the process inherent in CVGC has positive health outcomes outside of the outcomes related to the genetic test.

5.

researchgate.net

researchgate.net/publication/396642400_5-025_Mainstreaming_genetic_testing_in_a_heart_failure_service

5-025 Mainstreaming genetic testing in a heart failure service

The rate of positive tests is around 16% and higher in those with a positive family history (30%) compared to those without (12.5%). Education and training of ...

6.

heart.bmj.com

heart.bmj.com/content/111/Suppl_3/A167.1

5-025 Mainstreaming genetic testing in a heart failure service

17 (30%) individuals had a significant family history and yielded 5 positive results and one high polygenic risk score. 5 further positives were obtained from ...

7.

nature.com

nature.com/articles/s41431-023-01400-1

Interventions to support patients with sharing genetic test ...

Genetic testing is being increasingly used to identify genetic predisposition to disease due to the mainstreaming of genetic testing through, ...