Incidence and Predictors of Post-TIPS Heart Failure in Patients With Cirrhosis

NCT ID: NCT05596253

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2025-07-31

Brief Summary

The purpose of this study is to conduct a prospective trial to investigate the incidence of heart failure in cirrhosis patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the the predictors and modififications of cardiac function.

Detailed Description

Hyperdynamic circulation is a common Phenomenon in cirrhosis due to systemic and splanchnic vasodilatation, which may result cardic dysfunction and abnormal structure ,called cirrhotic cardiomyopathy(CCM). Transjugular intrahepatic portosystemic shunt (TIPS), as a effective technique to alleviates portal hypertension in cirrhotic patients, often be used to treat with refractory ascites and variceal bleeding which endoscopy and drug therapy are ineffective. However, owing to the increased shunting of blood from the splanchnic vascular bed into the central vascular bed, TIPS further exacerbates the hyperdynamic circulatory state, which may lead to heart failure.yet there are no convincing research to study the incidence of heart failure in cirrhosis after transjugular intrahepatic portosystemic shunt. The purpose of this study is to conduct a prospective trial to investigate the incidence of heart failure in cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the the predictors and modififications of cardiac function.

Conditions

Liver Cirrhosis; Transjugular Intrahepatic Portosystemic Shunt (TIPS); Heart Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with cirrhosis who underwent TIPS

Patients with cirrhosis who underwent TIPS due to complications of portal hypertension were inclueded for observation.

TIPS

Intervention Type: PROCEDURE

TIPS: Established distributary channel between the portal vein and hepatic vein via the jugular vein, portal vein blood directly shunts into the systemic circulation to reduce portal vein pressure to effectively prevent bleeding and refractory ascites.

Interventions

TIPS

TIPS: Established distributary channel between the portal vein and hepatic vein via the jugular vein, portal vein blood directly shunts into the systemic circulation to reduce portal vein pressure to effectively prevent bleeding and refractory ascites.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Cirrhosis

2. TIPS is placed successfully

3. Agree to participate in the trial

Exclusion Criteria

1. Non-cirrhotic portal hypertension

2. Previous TIPS or surgical shunt

3. Medium to severe pulmonary hypertension

4. Heart failure

5. End-stage renal disease requiring hemodialysis

6. Respiratory failure

7. Malignancies with a life expectancy of less than 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

luo xuefeng

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xuefeng luo

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuefeng Luo

Role: CONTACT

luo_xuefeng@yeah.net

+86 18980606826

Facility Contacts

Xuefeng Luo, MD，PhD

Role: primary

Other Identifiers

HF-TIPS

Identifier Type: -

Identifier Source: org_study_id