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Not yet recruitingNCT07880639Updated Oct 19, 2026

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

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

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
127
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Liver Diseases

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03

In context

Liver Diseases

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.

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Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients undergoing TIPS/DIPS

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. Age > 18 years
  2. All patients undergoing TIPS/DIPS

Exclusion criteria

Exclusion Criteria:

  1. Patients with no pre TIPS/DIPS Echocardiography
  2. Patients with no pre TIPS/DIPS NT Pro BNP
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
127 participants (estimated)
Patient registry
No

Groups and cohorts

  • All patients undergoing TIPS/DIPS

    All patients undergoing TIPS/DIPS with age\> 18 years

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. Incidence of post TIPS/DIPS heart failure within first 6 months at ILBS

    Time frame: 6 months

Secondary outcomes

  1. 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

  2. Incidence of liver failure post TIPS.

    Time frame: 6 months

  3. Incidence of new or worsening ascites, HE.

    Time frame: 6 months

  4. 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

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Study locations

1 site
  • Institute of Liver & Biliary Sciences (ILBS)
    New Delhi, National Capital Territory of Delhi 110070, India
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07880639
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Sep 27, 2026 (estimated)
Primary completion
Feb 28, 2028 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Oct 19, 2026

Study contacts

Dr Settipally Vinay Kumar, MD
Contact
settipallyvsk@gmail.com
01146300000
Dr Manoj Kumar Sharma, DM
Contact
manojkumardm@gmail.com
01146300000

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 not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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