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

NCT05596253 | Recruiting

• 1 other identifier: HF-TIPS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of heart failue

  Heart failue assessed by2021 ESC Guidelines

  up to 36 months

Secondary Outcomes (3)

• Predictors of heart Failure

  up to 36 months

• mortality

  up to 36 months

• Modififications of cardiac function

  up to 36 months

Study Arms (1)

Patients with cirrhosis who underwent TIPS

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

Procedure: TIPS

Interventions

TIPS 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.

Patients with cirrhosis who underwent TIPS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

cirrhotic patients undergoing TIPS

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Heart Failure

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• xuefeng luo

  Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefeng Luo

CONTACT

+86 18980606826; luo_xuefeng@yeah.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 27, 2022
• Study Start: October 11, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CN (1)