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临床试验/NCT03905421
NCT03905421已完成不适用

Quality of Life Assessed With the PAH SYMPACT Questionnaire in the Pulmonary Hypertension Clinic

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2019年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
390
试验地点
1
主要终点
Quality of life in pulmonary hypertension subjects

研究概览

简要总结

Researchers are evaluating quality of life in pulmonary hypertension subjects using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire and assessing the questionnaires' performance with regard to relationship to other markers of disease severity, response to treatment, and outcome in a clinical practice setting.

详细描述

Subjects will be recruited from among those seen at the Mayo Pulmonary Hypertension Clinic. The PAH-SYMPACT questionnaire will be administered either in written form or by telephone interview.

On the second 100 patients implement a standardized palliative care referral program for patients with Group 1 and 3 PH and high SYMPACT scores> 1.0.

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

入选标准

  • Age 18 years or above
  • Consents to participate
  • Documented group I PAH based upon these hemodynamic criteria: (mPAP > 20, PCW 18 or less, PVR > 3 Wood units
  • Mean PAP > 20, PCW ≤ 18, PVR > 3 Wood units
  • Parenchymal lung disease that in the opinion of the investigator qualifies patient as group III PH
  • Documented chronic thromboembolic pulmonary hypertension or chronic thromboembolic disease with intent to treat with surgery, balloon pulmonary angioplasty, and/or PH medication

排除标准

  • Left sided heart disease (LVEF<50%, PAWP>18)
  • Any other known concomitant life-threatening disease with a life expectancy <12 months
  • Any other clinically relevant and/or serious chronic medical condition that would affect study participation in the opinion of the investigator
  • Non English speaking

结局指标

主要结局

Quality of life in pulmonary hypertension subjects

时间窗: 14 months

Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire using a scale of 0=no, 1=mild, 2=moderate, 3=severe, and 4=very severe

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilary M. DuBrock, MD

Principal Investigator

Mayo Clinic

研究点 (1)

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