Nonischemic CardiomyopathyHOGINCT07345338
Mainstreaming Genetic Testing for Non-Ischemic Cardiomyopathy in Western Canada
A study testing Health service delivery change in people with Nonischemic Cardiomyopathy and Dilated Cardiomyopathy (DCM), run by Thomas Roston at 4 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
- What is being tested?
- Health service delivery change
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesCanada
- Study dates
- 2 Feb 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previously known genetic result that explains NICM/DCM
- Under age 18 years
- Declines genetic testing
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites
Peter Lougheed Centre Cardiac Function Clinic
Calgary, Alberta, T1Y6J4
Foothills Medical Centre Cardiac Function Clinic
Calgary, Alberta, T2N2T9
Vancouver General Hospital Cardiac Function Clinic
Vancouver, British Columbia, V5Z 1M9
St. Paul's Hospital Heart Function Clinic
Vancouver, British Columbia, V6Z1Y6
About this study
Official 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
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.
- Being tested
- Health service delivery change
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health service delivery changeOther
Genetic testing for patients with unexplained non-ischemic cardiomyopathy offered directly by cardiologists in Heart Function Clinics
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Health service delivery change |
| Traditional Referral Pathway for Genetic Testing | No intervention | Traditional referral pathway to a specialized cardiac genetics clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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
Measured: Up to 12 months after return of genetic test results
Patient-reported satisfaction, knowledge, and decision quality related to genetic testing
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
Measured: At 12 months after first participant enrollment
Proportion of participants with a change to family screening recommendations following 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
Measured: Up to 12 months after return of genetic test results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start2 Feb 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonischemic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster randomized crossover trial with 4 sites (each province will have an intervention and control site; allocations will remain in place for the first 4 months - after 4 months, the sites switch allocations and begin enrolling new participants under these allocations).
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Roston
- Sponsor type
- University, hospital or other
- Collaborators
- Genome British Columbia, Genome Alberta, University of Calgary
- Responsible party
- Sponsor-investigator, Thomas Roston, Cardiology Research UBC
- Investigators
- Thomas Roston, MD/PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345338
- Sponsor's protocol ID
- H25-02075
- Acronym
- HOGI
- Status last verified
- May 2026
- First submitted
- 2 Dec 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07345338
- Acronym / sponsor ID
- HOGI / H25-02075
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Thomas RostonUniversity, hospital or other
- Collaborators
- Genome British Columbia, Genome Alberta, University of Calgary
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized crossover trial with 4 sites (each province will have an intervention and control site; allocations will remain in place for the first 4 months - after 4 months, the sites switch allocations and begin enrolling new participants under these allocations).
| Arm | Type | Receives |
|---|---|---|
| Mainstreamed Genetic Testing through Heart Function Clinics | Experimental | Other: Health service delivery changeMainstreamed genetic testing offered directly by the Heart Function Clinic cardiologist with video-based genetic counselling tools |
| Traditional Referral Pathway for Genetic Testing | No intervention | –Traditional referral pathway to a specialized cardiac genetics clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Previously known genetic result that explains NICM/DCM
- Under age 18 years
- Declines genetic testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health service delivery changeGenetic testing for patients with unexplained non-ischemic cardiomyopathy offered directly by cardiologists in Heart Function Clinics | Other | Mainstreamed Genetic Testing through Heart Function Clinics |
Primary outcome
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.
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.
3 secondary outcomes
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
Patient-reported satisfaction, knowledge, and decision quality related to genetic testing
Time frame: At 12 months after first participant enrollment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Roston, MD/PhD principal investigator
University of British Columbia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health service delivery change in people with Nonischemic Cardiomyopathy and Dilated Cardiomyopathy (DCM), run by Thomas Roston at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of genetic testing for non-ischemic cardiomyopathy (NICM) (time frame: Through 12 months after first participant enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.