An observational study in Liver Diseases, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Institute of Liver and Biliary Sciences, India · Observational
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.
2,094 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 127 is below the median of 165 across 689 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients undergoing TIPS/DIPS
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Exclusion Criteria:
All patients undergoing TIPS/DIPS with age\> 18 years
Other: No intervention
No intervention
Incidence of post TIPS/DIPS heart failure within first 6 months at ILBS
Time frame: 6 months
Risk factors associated with new onset heart failure post TIPS
hazard ratio will be used to assess the association of various risk factors such pressure will be measured in cm water or mmHg, dimensions will be measured in cm and mm, velocity will be measured in cm/sec
Time frame: 6 months
Incidence of liver failure post TIPS.
Time frame: 6 months
Incidence of new or worsening ascites, HE.
Time frame: 6 months
Development of Clinical Prediction Model for screening patients that are at high risk for heart failure.
Logistic regression will be used to identify factors which are associated and equation will be made
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India →