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HCMR Re-Imaging Study

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

∙ Patients in the original HCMR cohort with:

• Obstructive HCM

‣ Males and females between 18 and 65 years of age

⁃ BMI \< 35 kg/m2

⁃ LVOT-G at entry as follows:

• 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

‣ Same criteria as above except resting LVOT-G is \<30mmHg and post-Valsalva gradient \<50mm Hg

⁃ BMI \<40kg/m2

⁃ Elevated NT-proBNP \> 300 pg/mL at the time of enrollment

⁃ LVEF ≥55%

Locations
United States
Illinois
Northwestern
NOT_YET_RECRUITING
Evanston
Massachusetts
Brigham & Women's Hospital
NOT_YET_RECRUITING
Boston
Tufts Medical Center
NOT_YET_RECRUITING
Medford
Michigan
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
Virginia
University of Virginia
RECRUITING
Charlottesville
Other Locations
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
NOT_YET_RECRUITING
Birmingham
London Chest Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Gina Duda
gms4x@uvahealth.org
434-924-9553
Backup
Thuy Le
DZV5SQ@uvahealth.org
Time Frame
Start Date: 2026-03-30
Estimated Completion Date: 2027-07
Participants
Target number of participants: 314
Treatments
Obstructive HCM
Non-obstructive HCM
Sponsors
Collaborators: Mayo Clinic, Toronto General Hospital, Northwestern University, Brigham and Women's Hospital, University of Michigan, London Chest Hospital, Tufts Medical Center, The Cleveland Clinic, University Hospital Birmingham NHS Foundation Trust, Glenfield Hospital, Leicester, Cytokinetics
Leads: Christopher Kramer

This content was sourced from clinicaltrials.gov