Eisenmenger Quality Enhancement Research Initiative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 主要终点
- Characterization of the clinical course of patients with Eisenmenger Syndrome
研究概览
简要总结
Eisenmenger Quality Enhancement Research Initiative (QuERI) is a multi-center, observational, US-based longitudinal program, with enrollment of consecutive Eisenmenger patients who meet enrollment. Patient data will be collected prospectively for three years. Individual physician feedback will be provided on data collected with the purpose of improving the management of patients - quality enhancement research initiative (QuERI) process.
详细描述
Approximately 200 male and female adult patients with a history of Eisenmenger will be recruited from approximately 50 cardiology practices over a period of 18 months and will be followed up every six months for the period of three years. Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study. Participating sites will be asked to maintain a screening log to identify which inclusion or exclusion criteria was not met thus excluding them from the study.
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
- •Male and female patients
- •Diagnosis of Eisenmenger syndrome based on right heart catheterization data
- •Right to Left intra-cardiac shunting
- •Need for comprehensive management according to guidelines and peer-reviewed evidence
- •Ability and desire to execute the consent for follow up
排除标准
- •Poor mental function, drug, or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
- •Prior inclusion in this program
结局指标
主要结局
Characterization of the clinical course of patients with Eisenmenger Syndrome
时间窗: up to 3 years
The management of Eisenmenger Syndrome patients over the three year registry period will be compared with established national guidelines. In addition, The Minnesota Living with Heart Failure questionnaire (MLHFQ) will be collected.
次要结局
- Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications.(baseline (visit 1) thru end of study (3 years))
- Characterization of the demographics of patients with Eisenmenger Syndrome(baseline (visit 1) thru end of study (3 years))
- Identification of clinical predictors of short-term and long-term outcomes of patients with Eisenmenger Syndrome.(baseline (visit 1) thru end of study (3 years))