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Status unknownNCT05596253Updated Apr 12, 2024

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

An observational study in Liver Cirrhosis, Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Heart Failure, sponsored by West China Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by West China Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Cirrhosis
  • Transjugular Intrahepatic Portosystemic Shunt (TIPS)
  • Heart Failure
03

In context

Liver Cirrhosis

1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.

This study's planned enrollment of 200 is above the median of 152 across 605 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

West China Hospital is the lead sponsor of 497 studies on the registry; 243 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

cirrhotic patients undergoing TIPS

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureTIPS

    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.

06

What researchers measure

Primary outcomes

  1. Incidence of heart failue

    Heart failue assessed by2021 ESC Guidelines

    Time frame: up to 36 months

Secondary outcomes

  1. Predictors of heart Failure

    Heart failue assessed by2021 ESC Guidelines

    Time frame: up to 36 months

  2. mortality

    Telephone follow-up was performed to collect relevant information

    Time frame: up to 36 months

  3. Modififications of cardiac function

    Echocardiography was to evaluate cardic function

    Time frame: up to 36 months

07

Study locations

1 of 1 sites recruiting
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610000, China
    • Xuefeng Luo, MD,PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05596253
Responsible party
luo xuefeng (MD, West China Hospital) — Principal investigator
First posted
Oct 27, 2022
Start date
Oct 11, 2022
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Apr 12, 2024

Study contacts

Xuefeng Luo
Contact
luo_xuefeng@yeah.net
+86 18980606826
xuefeng luo
principal investigator · Sichuan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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