Risk Stratification and Benefits With Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Change in 6-minute hall walk distance between baseline and subsequent follow-up
研究概览
简要总结
This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.
详细描述
The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated.
This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Meets current clinical indications for CRT-D therapy
- •Patient is 18 years old or older
- •Ability to independently comprehend and complete all QOL questionnaires
- •Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
- •Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up
排除标准
- •Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
- •Myocardial infarction in the last 3 weeks
- •Unstable angina in the last 3 weeks
- •Status 1 classification for cardiac transplantation
- •Currently participating in a clinical trial that includes an active treatment arm
- •Life expectancy of less than 12 months.
- •Recent (within 1 week) administration of Nesiritide™ or inotropes
- •Patients in whom revascularization is expected
- •Patient is pregnant
结局指标
主要结局
Change in 6-minute hall walk distance between baseline and subsequent follow-up
时间窗: 12 months
Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36)
时间窗: 12 months
The occurrence of either death (all-cause) or first HF hospitalization.
时间窗: 12 months
次要结局
- Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index(12 months)
- Quality of Life(12 months)
- Cause-specific mortality(12 months)