Clinical trial NCT01417338: Registry for Pulmonary Hypertension in China
Official title: National, Prospective, Multicenter,Observational Registry Study on Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Death
Keywords: Hypertension,pulmonary
Mortality
Risk factors
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 3079
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who were firstly diagnosed as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension at 53 participating institutions in China

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fu Wai Hospital
Study officials:
affiliation: Fu Wai Hospital
name: Jian-Guo He, M.D.
role: PRINCIPAL_INVESTIGATOR
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