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Recruiting NCT07054073

HCMR Re-Imaging Study

— Observational Hypertrophic Cardiomyopathy (HCM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: None - observational study.
Who it may be relevant to
Registry conditions: Hypertrophic Cardiomyopathy (HCM). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other None - observational study
    None - observational study

Primary outcome measures

  • Change in % LGE mass [Time frame: From baseline over a minimum of 7 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 6 centers
  • Northwestern — Evanston
  • Brigham & Women's Hospital — Boston
  • Tufts Medical Center — Medford
  • University of Michigan — Ann Arbor
  • Cleveland Clinic — Cleveland
  • University of Virginia — Charlottesville
United Kingdom · 2 centers
  • University Hospitals Birmingham NHS Foundation Trust — Birmingham
  • London Chest Hospital — London

Identifiers

NCT: NCT07054073 · 302244

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗