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Clinical Trials/NCT05596253
NCT05596253
Recruiting
Not Applicable

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

West China Hospital1 site in 1 country200 target enrollmentOctober 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cirrhosis
Sponsor
West China Hospital
Enrollment
200
Locations
1
Primary Endpoint
Incidence of heart failue
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 11, 2022
End Date
July 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

luo xuefeng

MD

West China Hospital

Eligibility Criteria

Inclusion Criteria

  • TIPS is placed successfully
  • Agree to participate in the trial

Exclusion Criteria

  • Non-cirrhotic portal hypertension
  • Previous TIPS or surgical shunt
  • Medium to severe pulmonary hypertension
  • Heart failure
  • End-stage renal disease requiring hemodialysis
  • Respiratory failure
  • Malignancies with a life expectancy of less than 6 months

Outcomes

Primary Outcomes

Incidence of heart failue

Time Frame: up to 36 months

Heart failue assessed by2021 ESC Guidelines

Secondary Outcomes

  • Predictors of heart Failure(up to 36 months)
  • mortality(up to 36 months)
  • Modififications of cardiac function(up to 36 months)

Study Sites (1)

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