Registry for Pulmonary Hypertension in China
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Purpose
- 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
- 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
- To evaluate differences in patient outcomes according to classification subgroup
- To identify clinical predictors of long-term survival
- To assess the relationship between targeted therapies for pulmonary arterial hypertension and patient outcomes
| Condition |
|---|
|
Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension Death |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | National, Prospective, Multicenter,Observational Registry Study on Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension in China |
- Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 3079 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Pulmonary hypertension group
Patients who were firstly diagnosed as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Consecutive patients who were firstly diagnosed as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension at 53 participating institutions in China
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
Contacts and Locations| Contact: Jian-Guo He, M.D. | 86-10-88398060 | hejianguofw@gmail.com |
| China | |
| Fu Wai Hospital | Recruiting |
| Beijing, China, 100037 | |
| Contact: Jian-Guo He, M.D. & Ph.D 86-10-88398060 hejianguofw@gmail.com | |
| Principal Investigator: | Jian-Guo He, M.D. | Fu Wai Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Jian-Guo He, Fu Wai Hospital |
| ClinicalTrials.gov Identifier: | NCT01417338 History of Changes |
| Other Study ID Numbers: | CIFuwaiHospital |
| Study First Received: | June 28, 2011 |
| Last Updated: | August 15, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Cardiovascular Institute & Fuwai Hospital:
|
Hypertension,pulmonary Mortality Risk factors |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases |
Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013