REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,515
- 试验地点
- 53
- 主要终点
- Survival
研究概览
简要总结
The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria at participating institutions will be enrolled. Participating patients will be followed for a minimum of five years from the time of enrollment.
详细描述
Pulmonary arterial hypertension (PAH) is a chronic, progressive, and often fatal disease characterized by severe constriction of the blood vessels in the lungs. Over the past decade, significant strides have been made in the medical management and understanding of PAH. However, much remains to be learned about the clinical course of both idiopathic PAH and associated PAH, including clinical presentation, pace of progression, key parameters to monitor, impact of treatment, and prognosticators of outcome. As the unique body of knowledge generated by the REVEAL Registry grows, it is hoped that new understandings, insights, and treatments will emerge that will improve the lives of patients with PAH.
The REVEAL Registry will provide investigators with descriptive data regarding the clinical course and treatment outcomes in patients with WHO Group I PAH. Data derived from the study may offer important tools for assessing current management practices of treating investigators, as well as changes over time. Additionally, the relationship of patient- and disease-specific parameters to patient outcomes may be able to be assessed through analysis of data from this study.
The specific objectives of the REVEAL Registry™ are to:
- Characterize the demographics and clinical course of PAH patients
- Evaluate and compare patient outcomes
- Identify clinical predictors of short-term and long-term clinical outcomes
- Assess the relationship between PAH medications and patient outcomes
- Report temporal trends in treatments and outcomes for newly diagnosed patients
- Collect timely and relevant data for the evolving research needs of the PAH community
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
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed or previously diagnosed patients with WHO Group I PAH.
- •Documentation of the following hemodynamic parameters by right heart catheterization, performed at any time prior to study enrollment:
- •Mean pulmonary arterial pressure (mPAP) >25 mm Hg at rest or mPAP > 30 mm Hg with exercise contemporaneous with a pulmonary wedge pressure ≤ 18 mm Hg
- •Pulmonary wedge pressure ≤ 18 mm Hg
- •Pulmonary vascular resistance (PVR) ≥ 240 dynes.sec.cm-5 (i.e., ≥ 3.0 Wood units)
排除标准
- •Patients who meet the criteria for inclusion into WHO Groups II, III, IV or V
- •Have not had documentation of hemodynamic criteria for PAH by right heart catheterization at some time preceding study entry and following development of symptoms associated with PAH.
- •Do not meet the required hemodynamic criteria for entry into the study
结局指标
主要结局
Survival
时间窗: 5 years
次要结局
- clinical predictors, precise outcome definitions(5 years)