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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Mayo Clinic | OTHER |
| Tufts Medical Center | OTHER |
| Northwestern University |
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This study aims to learn what might predict heart problems (like sudden death from a fast heart rhythm or heart failure) in people with a genetic condition called hypertrophic cardiomyopathy (HCM). HCM causes the heart muscle to become thick, which can make the heart stiff and harder to work properly. It can also affect the heart's electrical system.
This study is looking to enroll patients that were previously part of a research project called "HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy." The results of that study are still being reviewed, but they might show that people who had a substance called Gadolinium (MRI contrast or dye) collected in their heart muscle may have a higher risk for heart problems, including sudden cardiac death. This is called "late gadolinium enhancement" (LGE). This study is aiming to do follow-up imaging on those patients to better understand how LGE affects people with HCM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obstructive HCM |
| ||
| Non-obstructive HCM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None - observational study | Other | None - observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in % LGE mass | To assess the change in LGE extent from baseline over a minimum of 7 years of follow-up extent in HCM patients who would have been candidates for clinical trials of aficamten. | From baseline over a minimum of 7 years |
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Inclusion Criteria:
Patients in the original HCMR cohort with:
Obstructive HCM
Resting gradient ≥50 mmHg OR Resting gradient ≥30 mmHg and <50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
• NYHA Class II or III or
Non-obstructive HCM
Exclusion Criteria:
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Participants from the HCMR original cohort who also meet this study's eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gina Duda | Contact | 434-924-9553 | gms4x@uvahealth.org | |
| Thuy Le | Contact | DZV5SQ@uvahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Kramer, MD | University of Virginia | Principal Investigator |
| Stefan Neubauer, MD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern | Not yet recruiting | Evanston | Illinois | 60208 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2025 | Jun 27, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2025 | Jun 27, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| OTHER |
| University of Michigan | OTHER |
| The Cleveland Clinic | OTHER |
| University Hospital Birmingham NHS Foundation Trust | OTHER |
| Glenfield Hospital, Leicester | OTHER |
| London Chest Hospital | UNKNOWN |
| Cytokinetics | INDUSTRY |
| Toronto General Hospital | OTHER |
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| Brigham & Women's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
|
| Tufts Medical Center | Not yet recruiting | Medford | Massachusetts | 02155 | United States |
|
| University of Michigan | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| University Hospitals Birmingham NHS Foundation Trust | Not yet recruiting | Birmingham | B15 2GW | United Kingdom |
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| London Chest Hospital | Not yet recruiting | London | E2 9JX | United Kingdom |
|
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |