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临床试验/NCT02743091
NCT02743091已完成不适用

Idiopathic Pre-capillary Pulmonary Hypertension in Patients With End-stage Kidney Disease

Toujinkai Hospital0 个研究点目标入组 1,988 人开始时间: 2001年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,988
主要终点
Number of patients of idiopathic pre-capillary hypertension

研究概览

简要总结

This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary hypertension (PH) in patients with end-stage kidney disease (ESKD).

详细描述

Pulmonary hypertension (PH) is a rare cardiovascular disease with progressive and fatal features. PH is classified into the 5 groups, and the prevalence of group 1 pulmonary arterial hypertension, including idiopathic and heritable, is 5 to 15 cases per one million adults and a median survival was reportedly three years. PH found in patients with end-stage kidney disease (ESKD) is classified into group 5, because the pathogenesis and clinical characteristics have not been clarified. The prevalence of PH in patients with ESKD was reportedly around 17~56% based on echocardiographic studies. In this study, we evaluated the incidence of idiopathic pre-capillary PH of ESKD patients by right heart catheterization, and examined the prognosis by following the occurrence of heart failure death.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptoms of dyspnea, hypotension (systolic blood pressure <90mmHg, or syncope.
  • Systolic pressure gradients in tricuspid valve of 40 mmHg or more.
  • In right heart catheterization, precapillary PH was defined as mean pulmonary arterial pressure (PAP) ≥25 mmHg, pulmonary vascular resistance (PVR) ≥3 wood unit, and pulmonary artery wedge pressure (PAWP) ≤15 mmHg.

排除标准

  • Patients with systolic left ventricular dysfunction (left ventricular ejection fraction [LVEF] <50%), mitral or aortic regurgitation of grade 2 or more, aortic or mitral surface <1.5 cm2, severe anemia (blood hemoglobin <9 g/dl), severe chronic obstructive pulmonary disease defined by percent predicted forced expiratory volume in one second <60%, or lung fibrosis were not enrolled in this study.
  • In right hear catheterization, PAP ≥25 mmHg and PAWP >15 mmHg were diagnosed as post capillary PH.

结局指标

主要结局

Number of patients of idiopathic pre-capillary hypertension

时间窗: 14 years

次要结局

  • Number of patients who died of heart failure(14 years)

研究者

发起方
Toujinkai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Masato Nishimura, MD

Director of Cardiovascular Division

Toujinkai Hospital

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