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NCT01417338 Clinical Trial

Registry for Pulmonary Hypertension in China

Pulmonary Arterial Hypertension Clinical Trial

Official title:
National, Prospective, Multicenter,Observational Registry Study on Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension in China

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01417338
Other study ID # CIFuwaiHospital
Secondary ID
Status Recruiting
Phase N/A
First received June 28, 2011
Last updated June 7, 2017
Start date August 2009
Est. completion date December 2020

Study information
Verified date June 2017
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact Jian-Guo He, M.D.
Phone 86-10-88398060
Email hejianguofw@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3079
Est. completion date December 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Fu Wai Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

References & Publications (16)

Badesch DB, Raskob GE, Elliott CG, Krichman AM, Farber HW, Frost AE, Barst RJ, Benza RL, Liou TG, Turner M, Giles S, Feldkircher K, Miller DP, McGoon MD. Pulmonary arterial hypertension: baseline characteristics from the REVEAL Registry. Chest. 2010 Feb;137(2):376-87. doi: 10.1378/chest.09-1140. Epub 2009 Oct 16. — View Citation

Benza RL, Miller DP, Gomberg-Maitland M, Frantz RP, Foreman AJ, Coffey CS, Frost A, Barst RJ, Badesch DB, Elliott CG, Liou TG, McGoon MD. Predicting survival in pulmonary arterial hypertension: insights from the Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management (REVEAL). Circulation. 2010 Jul 13;122(2):164-72. doi: 10.1161/CIRCULATIONAHA.109.898122. Epub 2010 Jun 28. — View Citation

D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. — View Citation

Duffels MG, Engelfriet PM, Berger RM, van Loon RL, Hoendermis E, Vriend JW, van der Velde ET, Bresser P, Mulder BJ. Pulmonary arterial hypertension in congenital heart disease: an epidemiologic perspective from a Dutch registry. Int J Cardiol. 2007 Aug 21;120(2):198-204. Epub 2006 Dec 19. — View Citation

Fasnacht MS, Tolsa JF, Beghetti M; Swiss Society for Pulmonary Arterial Hypertension.. The Swiss registry for pulmonary arterial hypertension: the paediatric experience. Swiss Med Wkly. 2007 Sep 8;137(35-36):510-3. — View Citation

Fischler M, Speich R, Dorschner L, Nicod L, Domenighetti G, Tamm M, Rochat T, Aubert JD, Ulrich S; Swiss Society for Pulmonary Hypertension.. Pulmonary hypertension in Switzerland: treatment and clinical course. Swiss Med Wkly. 2008 Jun 28;138(25-26):371-8. doi: 2008/25/smw-11914. — View Citation

Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaïci A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Cottin V, Degano B, Jaïs X, Montani D, Souza R, Simonneau G. Survival in patients with idiopathic, familial, and anorexigen-associated pulmonary arterial hypertension in the modern management era. Circulation. 2010 Jul 13;122(2):156-63. doi: 10.1161/CIRCULATIONAHA.109.911818. Epub 2010 Jun 28. — View Citation

Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaici A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Simonneau G. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med. 2006 May 1;173(9):1023-30. Epub 2006 Feb 2. — View Citation

Jing ZC, Xu XQ, Han ZY, Wu Y, Deng KW, Wang H, Wang ZW, Cheng XS, Xu B, Hu SS, Hui RT, Yang YJ. Registry and survival study in chinese patients with idiopathic and familial pulmonary arterial hypertension. Chest. 2007 Aug;132(2):373-9. Epub 2007 Mar 30. — View Citation

McGoon MD, Krichman A, Farber HW, Barst RJ, Raskob GE, Liou TG, Miller DP, Feldkircher K, Giles S. Design of the REVEAL registry for US patients with pulmonary arterial hypertension. Mayo Clin Proc. 2008 Aug;83(8):923-31. doi: 10.4065/83.8.923. — View Citation

Mukerjee D, St George D, Coleiro B, Knight C, Denton CP, Davar J, Black CM, Coghlan JG. Prevalence and outcome in systemic sclerosis associated pulmonary arterial hypertension: application of a registry approach. Ann Rheum Dis. 2003 Nov;62(11):1088-93. — View Citation

Rich S, Dantzker DR, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Koerner SK, et al. Primary pulmonary hypertension. A national prospective study. Ann Intern Med. 1987 Aug;107(2):216-23. — View Citation

Rich S, Rubin L, Walker AM, Schneeweiss S, Abenhaim L. Anorexigens and pulmonary hypertension in the United States: results from the surveillance of North American pulmonary hypertension. Chest. 2000 Mar;117(3):870-4. — View Citation

Thenappan T, Shah SJ, Rich S, Gomberg-Maitland M. A USA-based registry for pulmonary arterial hypertension: 1982-2006. Eur Respir J. 2007 Dec;30(6):1103-10. Epub 2007 Sep 5. — View Citation

Tueller C, Stricker H, Soccal P, Tamm M, Aubert JD, Maggiorini M, Zwahlen M, Nicod L; Swiss Society for Pulmonary Hypertension.. Epidemiology of pulmonary hypertension: new data from the Swiss registry. Swiss Med Wkly. 2008 Jun 28;138(25-26):379-84. doi: 2008/25/smw-11915. — View Citation

Zhang R, Dai LZ, Xie WP, Yu ZX, Wu BX, Pan L, Yuan P, Jiang X, He J, Humbert M, Jing ZC. Survival of Chinese patients with pulmonary arterial hypertension in the modern treatment era. Chest. 2011 Aug;140(2):301-309. doi: 10.1378/chest.10-2327. Epub 2011 Feb 17. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Survival 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. 5 years
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