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NCT Number: NCT07054073

HCMR Re-Imaging Study

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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Key information

Conditions

Hypertrophic Cardiomyopathy (HCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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%

Exclusion criteria

Paroxysmal atrial fibrillation or flutter documented prior to entry.
Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) ≤6 months prior to entry. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months.)
History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to entry.
Pregnancy due to potential risk of gadolinium to the fetus
Patients with a pacemaker that are pacer-dependent as they cannot undergo MRI

Treatment and study plan

None - observational study

Other

None - observational study

Primary outcomes

Change in % LGE mass

Time frame: From baseline over a minimum of 7 years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gina Duda

CONTACT

[email protected]

434-924-9553

Thuy Le

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Christopher Kramer

Other

Collaborators

Brigham and Women's Hospital
Cytokinetics
Glenfield Hospital, Leicester
London Chest Hospital
Mayo Clinic
Northwestern University
The Cleveland Clinic
Toronto General Hospital
Tufts Medical Center
University Hospital Birmingham NHS Foundation Trust
University of Michigan

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 8, 2025
Registry last updated: Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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