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Clinical Trials/NCT05596253
NCT05596253RecruitingNot 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 enrollmentStarted: October 11, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
Incidence of heart failue

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

luo xuefeng

MD

West China Hospital

Study Sites (1)

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