Reverse Remodeling After PTSMA in Severe But ASympTomAtic LVOT Obstruction (RASTA Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Deformation (CMR)
研究概览
简要总结
Patients with HOCM and severe LVOT obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders. Hence, preventing adverse remodeling through LVOT desobstruction may have significant impact on cardiac function and geometry in this particular population, as it is in symptomatic patients.
The investigators will assess functional and structural characteristics of the myocardium in asymptomatic vs. symptomatic patients with severe LVOT obstruction before and after PTSMA, using advanced imaging studies with LGE-CMR and echocardiography.
详细描述
The trial consists of three cohorts
- Symptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (reference group)
- Asymptomatic HOCM patients with severe LVOT obstruction undergoing PTSMA (study group)
- Asymptomatic HOCM patients with severe LVOT obstruction with no intervention (observation group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Technicians and/or imaging cardiologists involved in image analysis will not be informed about the procedure in order to have an unbiased analysis at baseline. At follow-up, treated patients will have akinetic/infarcted proximal septum that will be noticed during image acquisition. However, the pre-PTSMA status (symptomatic vs. asymptomatic) will be blinded for the analysis.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 40 yrs
- •HOCM diagnosed by experienced cardiologists (European Society of Cardiology (ESC)-certified imaging cardiologists and/or finalized fellowship imaging)
- •LVOT obstruction >30 mmHg pressure gradient in rest, or >50 mmHg during exercise by TTE and/or invasive measurement, performed experienced (imaging) cardiologists
- •Symptomatic (NYHA class >2 or CCS class >2)
- •Asymptomatic: free of any dyspnea/chest pain or discomfort associated with LVOT obstruction
排除标准
- •LV wall thickness <15 mm
- •Other conditions responsible for hypertrophy (e.g. hypertension, aortic valve disease)
- •Moderate to severe mitral valve regurgitation
- •Systolic anterior motion of the mitral valve
- •Coronary artery disease requiring intervention
- •Pregnancy
结局指标
主要结局
Deformation (CMR)
时间窗: 2 years
Shortening Index
Haemodynamics
时间窗: 2 years
Left and Right-Sided Pressure Gradients (TTE)
4D velocity mapping
时间窗: 2 years
Blood Flow
Global longitudinal strain (TTE)
时间窗: 2 years
Diastolic Function
Fibrosis
时间窗: 2 years
Extracellular Volume Fraction
LV Geometry
时间窗: 2 years
Volume
次要结局
- New York Heart Association (NYHA) classification(2 years)
研究者
J.M. ten Berg
Principal Investigator
St. Antonius Hospital