Registry for Pulmonary Hypertension in China

• Conditions: Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Death

• Registration Number: NCT01417338
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

1. To characterize the demographics and clinical course of the patient population diagnosed as having WHO group I pulmonary arterial hypertension and WHO group IV pulmonary hypertension due to chronic thromboembolic pulmonary hypertension

2. To describe real-world outcome of Chinese patients with WHO group I pulmonary arterial hypertension and WHO group IV pulmonary hypertension due to chronic thromboembolic pulmonary hypertension

3. To evaluate differences in patient outcomes according to classification subgroup

4. To identify clinical predictors of long-term survival

5. To assess the relationship between targeted therapies for pulmonary arterial hypertension and patient outcomes

Detailed Description

Data describing the natural history of idiopathic and familial pulmonary arterial hypertension were derived from a registry conducted at our institution prior to 2006. Since then, targeted therapies for pulmonary arterial hypertension have been introduced in China. It is probably that the prognosis of Chinese patients with WHO group I pulmonary arterial hypertension and WHO group IV pulmonary hypertension due to chronic thromboembolic pulmonary hypertension has also been improved as western countries. Therefore, the aim of the present study was to describe real-world outcome of Chinese patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension and identify factors that may predict outcome. Our study will provide an updated picture of the clinical course of a more broadly defined scope of pulmonary hypertension and the effects of current therapy on survival, enabling the collection of data on demographics, clinical course, treatments, and outcomes.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-09
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3079

Inclusion Criteria

• Signed patients'consent
• Diagnosed by right heart catheterization one month within study enrollment
• patients who were firstly diagnosed as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension

Exclusion Criteria

• Not meeting inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	5 years	The time from diagnosis to the date of occurrence of death, or need to perform atrial Septostomy and lung transplantation, or to the deadline of the study. The average follow-up period is 5 years.

Trial Locations

Locations (1)

Fu Wai Hospital; 🇨🇳 Beijing, China