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

April 11, 2024 updated by: luo xuefeng, West China Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Xuefeng Luo, MD，PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

cirrhotic patients undergoing TIPS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of heart failue
Time Frame: up to 36 months
Heart failue assessed by2021 ESC Guidelines
up to 36 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: xuefeng luo, Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 23, 2022

First Submitted That Met QC Criteria

October 23, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF-TIPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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