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

Heart Failure Clinical Trial

Official title:

Incidence and Predictors of Post-TIPS (Transjugular Intrahepatic Portosystemic Shunt (TIPS) Heart Failure in Patients With Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596253
• Other study ID #: HF-TIPS
• Status: Recruiting
• Start date: October 11, 2022
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: West China Hospital
• Contact: Xuefeng Luo
• Phone: +86 18980606826
• Email: luo_xuefeng[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Heart Failure
• Liver Cirrhosis
• Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of heart failue	Heart failue assessed by2021 ESC Guidelines	up to 36 months
Secondary	Predictors of heart Failure	Heart failue assessed by2021 ESC Guidelines	up to 36 months
Secondary	mortality	Telephone follow-up was performed to collect relevant information	up to 36 months
Secondary	Modififications of cardiac function	Echocardiography was to evaluate cardic function	up to 36 months