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Registry for Pulmonary Hypertension in China

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ClinicalTrials.gov Identifier: NCT01417338
Recruitment Status : Recruiting
First Posted : August 16, 2011
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jianguo He, 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

Condition or disease
Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension Death

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 Type : Observational
Estimated Enrollment : 3079 participants
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
Study Start Date : August 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Group/Cohort
Pulmonary hypertension group
Patients who were firstly diagnosed as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension



Primary Outcome Measures :
  1. Survival [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417338


Contacts
Contact: Jian-Guo He, M.D. 86-10-88398060 hejianguofw@gmail.com

Locations
China
Fu Wai Hospital Recruiting
Beijing, China, 100037
Contact: Jian-Guo He, M.D. & Ph.D    86-10-88398060    hejianguofw@gmail.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
Principal Investigator: Jian-Guo He, M.D. Fu Wai Hospital

Additional Information:
Publications:

Responsible Party: Jianguo He, Director of Pulmonary vascular disease center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01417338     History of Changes
Other Study ID Numbers: CIFuwaiHospital
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital:
Hypertension,pulmonary
Mortality
Risk factors

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases