PRognosis of Outcome and Recuperation of Cardiac Hemodynamic Function After Aortic Valve REplacement in Aortic Valve Stenosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Outcome defined by the occurrence of a major cardiac event
研究概览
简要总结
Indication for aortic valve replacement (AVR) in aortic stenosis (AS) is currently based on the classical triad of clinical AS symptoms, estimation of AS severity, and cardiac repercussion at rest. However, presence of symptoms in elderly is often subjective and underreported, and cardiac function analysis at rest underestimates the true impact of the chronic afterload increase. This complicates the diagnosis and hampers timely aortic valve replacement therapy with an impact on prognosis and cardiac function recovery. Exercise imaging in AS may reveal underlying cardiac repercussion and symptoms at an earlier stage and therefore impact prognosis and cardiac function recovery after AVR. Therefore the principal objective of this study is to reveal the factors that determine clinical outcome and hemodynamic function recovery after AVR in AS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Every patient above 18 years of age with an echocardiographic established moderate to severe AS
- •A guideline indication for aortic valve replacement therapy
排除标准
- •Unable to perform exercise testing
- •Previous aortic valve intervention
- •More than moderate other valvular disease
- •Patients refusing participation or unwilling to sign the informed consent
结局指标
主要结局
Outcome defined by the occurrence of a major cardiac event
时间窗: 18 months
either 1. Death of cardiovascular origin, or 2. Hospitalization for heart failure, or 3. Deterioration of hemodynamic function during an 18 month follow-up period after AVR.
次要结局
未报告次要终点
研究者
Sarah Hoedemakers
Sarah Hoedemakers
Jessa Hospital