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NOT YET RECRUITING
NCT07880639

Incidence of Post TIPS/DIPS Heart Failure and the Factors Associated With Post-TIPS/DIPS Heart Failure.

Sponsor: Institute of Liver and Biliary Sciences, India

View on ClinicalTrials.gov

Summary

The creation of a transjugular intrahepatic portosystemic shunt (TIPS) or direct intrahepatic portosystemic shunt (DIPS) results in an acute increase in venous return and cardiac preload. These procedures are established therapies for refractory ascites, variceal bleeding, hydrothorax, and Budd-Chiari syndrome, they may unmask subclinical cardiac dysfunction. Incidence of heart failure after TIPS varies widely from 0-25%, reflecting heterogeneity in patient selection and the lack of prospective data. Several predictors-including elevated pre-procedure BNP/NT-proBNP, diastolic dysfunction (E/e' \>10, LAVI \>34 mL/m²), impaired GLS, and elevated right-sided pressures-have been described, but most evidence arises from retrospective studies with inconsistent definitions.This single-center prospective cohort study at ILBS aims to determine the true incidence of heart failure within 6 months of TIPS/DIPS and to identify independent predictors using comprehensive clinical, biochemical, echocardiographic, and invasive hemodynamic parameters. Heart failure is a clinical syndrome with symptoms and/or signs caused by structural and/or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion. In Echocardiography parameters GLS\<18 post TIPS for systolic function, E/e' average \> 15 for diastolic function will taken into consideration. In case of worsening diastolic function increase in grade of diastolic dysfunction ( measured by E/A)will be considered as post TIPS worsening.A total of 127 patients will be enrolled based on sample-size calculations assuming a 5% event rate. Findings will help create a clinically applicable predictive model to guide pre-TIPS cardiac risk stratification and optimize patient selection, thereby reducing morbidity and improving outcomes.

Official title: Incidence of Post TIPS/DIPS Heart Failure and the Factors Associated With Post-TIPS/DIPS Heart Failure- A Single Center Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

127

Start Date

2026-09-27

Completion Date

2028-02-28

Last Updated

2026-10-19

Healthy Volunteers

No

Conditions

Interventions

OTHER

No intervention

No intervention

Locations (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India