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

Recruiting

• Conditions: Heart Failure; Liver Cirrhosis; Transjugular Intrahepatic Portosystemic Shunt (TIPS)
• Interventions: Procedure: TIPS

• Registration Number: NCT05596253
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2022-10-11
• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-10-23
• Study First Posted: 2022-10-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Cirrhosis
2. TIPS is placed successfully
3. Agree to participate in the trial

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of heart failue	up to 36 months	Heart failue assessed by2021 ESC Guidelines

Secondary Outcome Measures

Name	Time	Method
Predictors of heart Failure	up to 36 months	Heart failue assessed by2021 ESC Guidelines
mortality	up to 36 months	Telephone follow-up was performed to collect relevant information
Modififications of cardiac function	up to 36 months	Echocardiography was to evaluate cardic function

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China