We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry for Pulmonary Hypertension in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01417338
Recruitment Status : Unknown
Verified June 2017 by Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was:  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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Jian-Guo He, M.D. 86-10-88398060 hejianguofw@gmail.com

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Jian-Guo He, M.D. Fu Wai Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jianguo He, Director of Pulmonary vascular disease center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01417338    
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:
Layout table for MeSH terms
Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases