Registry for Pulmonary Hypertension in China

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2009 by Cardiovascular Institute & Fuwai Hospital
Sponsor:
Information provided by:
Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01417338
First received: June 28, 2011
Last updated: August 15, 2011
Last verified: August 2009
  Purpose
  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
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

Resource links provided by NLM:


Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Cardiovascular Institute & Fuwai Hospital
Investigators
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 July 24, 2014