Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- LV end-diastolic volume (EDV) decrease
研究概览
简要总结
Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse remodeling of the left ventricle (LV) in the postoperative period. It is suggested that functional mitral regurgitation (MR) provides supra-physiological left ventricle volume overload and this fact plays positive role in early-stage post-operative left ventricle volume and function recovery. LV volume, systolic and diastolic function will be monitored with echocardiography (EchoCG) along with life quality in patients with different grades of functional mitral regurgitation secondary to severe chronic aortic insufficiency after surgical treatment of aortic regurgitation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Planned primary elective surgery for chronic aortic regurgitation
- •Presence of functional mitral regurgitation
- •End-diastolic volume of the left ventricle >= 250 ml
排除标准
- •Infectious endocarditis
- •History of myocardial infarction
- •Indications on simultaneous myocardial revascularisation
- •Acute aortic regurgitation of any etiology
- •Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation
- •Long-term persistent or permanent form of atrial fibrillation
- •Pregnancy in the first 12 months after surgery
- •Simultaneous participation in other studies
- •Presence of implanted pacemakers
- •Refusal to sign informed consent
- •Acute coronary event diagnosed within 12 months after aortic valve surgery
- •Indications for resynchronization therapy or permanent right ventricular pacing in the first 12 months after aortic valve surgery
- •Re-do cardiac surgery for any reason within 12 months after aortic valve surgery
结局指标
主要结局
LV end-diastolic volume (EDV) decrease
时间窗: 3 and 12 months after surgery
Change in end-diastolic volume of the left ventricle, assessed with EchoCG after surgical correction of aortic insufficiency
Freedom from readmission
时间窗: 12 months after surgery
Freedom from readmission due to valvular problem or heart failure-related reason
次要结局
- Life quality(Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery)