Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

Hypertension, Portal Clinical Trial

Official title:

Serum Biomarkers Associated With Endothelial Dysfunction and Immune Inflammation for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713606
• Other study ID #: Pan-CHESS1802
• Status: Recruiting
• Start date: September 30, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xiaolong Qi, M.D.
• Phone: +86 18588602600
• Email: qixiaolong[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multi-center diagnostic trial conducted at 6 liver centers in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and hepatic venous pressure gradient in cirrhosis.

Description:

Hepatic venous pressure gradient (HVPG) is the gold standard for assessing portal pressure, of which the measurement is invasive and therefore not suitable for routine clinical practice. The detection of serum biomarkers is potential for noninvasive diagnosis of portal hypertension in cirrhosis. However, many are still in the exploratory phases of testing and are not yet ready to enter clinical practice. This study prospectively enrolled participants in 6 liver centers (Beijing YouAn Hospital, Shandong Provincial Hospital, Beijing Shijitan Hospital, Beijing Friendship Hospital, Xingtai People's Hospital, and 302 Hospital of PLA) in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and HVPG in cirrhosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 1, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18-75 years;

• confirmed cirrhosis based on histologic examination of liver or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver.

Exclusion Criteria:

• prior drug therapy (e.g. ß-blocker, vasopressin) within two weeks

• prior surgeries (e.g. TIPS, partial splenic embolization/ devascularization, splenectomy, liver transplantation)

• non-sinusoidal portal hypertension & HCC inability to adhere to study procedures

• pregnancy or unknown pregnancy status

• no informed consent

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal

Intervention

Procedure:
• HVPG measurement
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.

Locations

Country	Name	City	State
China	302 Hospital of PLA	Beijing
China	Beijing Friendship Hospital	Beijing
China	Beijing Shijitan Hospital	Beijing
China	Beijing YouAn Hospital	Beijing
China	Shandong Provincial Hospital	Jinan
China	Xingtai People's Hospital	Xingtai

Sponsors (7)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Beijing 302 Hospital, Beijing Friendship Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing YouAn Hospital, Shandong Provincial Hospital, Xingtai People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Buck M, Garcia-Tsao G, Groszmann RJ, Stalling C, Grace ND, Burroughs AK, Patch D, Matloff DS, Clopton P, Chojkier M. Novel inflammatory biomarkers of portal pressure in compensated cirrhosis patients. Hepatology. 2014 Mar;59(3):1052-9. doi: 10.1002/hep.26755. Epub 2014 Jan 29. — View Citation

Ferlitsch M, Reiberger T, Hoke M, Salzl P, Schwengerer B, Ulbrich G, Payer BA, Trauner M, Peck-Radosavljevic M, Ferlitsch A. von Willebrand factor as new noninvasive predictor of portal hypertension, decompensation and mortality in patients with liver cirrhosis. Hepatology. 2012 Oct;56(4):1439-47. doi: 10.1002/hep.25806. Epub 2012 Aug 27. — View Citation

Groszmann RJ, Wongcharatrawee S. The hepatic venous pressure gradient: anything worth doing should be done right. Hepatology. 2004 Feb;39(2):280-2. Review. — View Citation

Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2. Review. — View Citation

Waidmann O, Brunner F, Herrmann E, Zeuzem S, Piiper A, Kronenberger B. Macrophage activation is a prognostic parameter for variceal bleeding and overall survival in patients with liver cirrhosis. J Hepatol. 2013 May;58(5):956-61. doi: 10.1016/j.jhep.2013.01.005. Epub 2013 Jan 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between serum biomarkers and HVPG	Correlation between serum biomarkers and HVPG	1 day
Secondary	Correlation between serum biomarkers and HVPG in HBV subgroup	Correlation between serum biomarkers and HVPG in a subgroup of patients with HBV-related cirrhosis	1 day