HCMR Re-Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 314
- 试验地点
- 8
- 主要终点
- Change in % LGE mass
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
Obstructive HCM
干预措施: None - observational study (Other)
Non-obstructive HCM
干预措施: None - observational study (Other)
结局指标
主要结局
Change in % LGE mass
时间窗: 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.
次要结局
未报告次要终点
研究者
Christopher Kramer
University of Virginia Health System
University of Virginia