跳至主要内容
临床试验/JPRN-jRCT1010220025
JPRN-jRCT1010220025招募中Unknown

A cohort study in HigAshi-nippon of Pulmonary hyPertensIoN in systEmic SclerosiS - HAPPINESS study

Kato Masaru0 个研究点目标入组 230 人开始时间: 2022年11月7日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
230

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
>= 18age old 至 ot applicable(—)
性别
All

入选标准

  • Patients who fall under 1, 2, 3, and 4 below are eligible.
  • 1.Age 18 years or older at the time of inclusion.
  • 2.Fulfilling 2013 ACR/EULAR classification criteria for systemic sclerosis or having scleroderma spectrum disorders (sclerodactyly or systemic sclerosis specific autoantibodies (anti-Scl-70, anti-centromere or anti-RNA polymerase III antibodies)) and fulfilling on of the following criteria;2004 MHLW classification criteria for mixed connective tissue disease,1997 ACR classification criteria for systemic lupus erythematosus, 2012 SLICC classification criteria for systemic lupus erythematosus, Bohan and Peter criteria for the diagnosis of polymyositis and dermatomyositis, or 2017 ACR/EULAR classification criteria for primary Sjogren's syndrome.
  • 3.Having had first right heart catheterization later than 2015 with suspicion of PH by unexplained dyspnea,increased NT-proBNP (more than twice the upper limit of normal), reduced pulmonary diffusing capacity (DLCO <60% or FVC/DLCO >1.6),and elevated tricuspid regurgitant velocity (>2.8m/s).
  • 4.A person who voluntarily agrees to participate in the study or who does not refuse to participate in the study.

排除标准

  • 1.A person who is judged by the principal investigator to be unsuitable as a research subject

研究者

发起方
Kato Masaru

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