Liver DiseasesNCT07880639
Incidence of Post TIPS/DIPS Heart Failure and the Factors Associated With Post-TIPS/DIPS Heart Failure.
An observational study of Liver Diseases, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- How many people
- 127 participants
- Where
- 1 siteIndia
- Study dates
- 27 Sep 2026to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing TIPS/DIPS
Who may be able to join
- Age > 18 years
- All patients undergoing TIPS/DIPS
Who cannot join
- Patients with no pre TIPS/DIPS Echocardiography
- Patients with no pre TIPS/DIPS NT Pro BNP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Settipally Vinay Kumar, MD, 01146300000, settipallyvsk@gmail.com
About this study
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
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.
- Conditions
- Liver Diseases
- Being tested
- No intervention
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| All patients undergoing TIPS/DIPS | All patients undergoing TIPS/DIPS with age> 18 years Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post TIPS/DIPS heart failure within first 6 months at ILBS
Measured: 6 months
Secondary outcomes (4)
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
Measured: 6 months
Incidence of liver failure post TIPS.
Measured: 6 months
Incidence of new or worsening ascites, HE.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start27 Sep 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880639
- Sponsor's protocol ID
- ILBS-TIPS-01
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07880639
- Acronym / sponsor ID
- ILBS-TIPS-01
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 27 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients undergoing TIPS/DIPS | – | Other: No interventionAll patients undergoing TIPS/DIPS with age> 18 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing TIPS/DIPS
Key inclusion criteria (2 listed)
- Age > 18 years
- All patients undergoing TIPS/DIPS
Key exclusion criteria (2 listed)
- Patients with no pre TIPS/DIPS Echocardiography
- Patients with no pre TIPS/DIPS NT Pro BNP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | All patients undergoing TIPS/DIPS |
Primary outcome
Incidence of post TIPS/DIPS heart failure within first 6 months at ILBS
Time frame: 6 months
4 secondary outcomes
Risk factors associated with new onset heart failure post TIPS
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.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Settipally Vinay Kumar, MD (01146300000, settipallyvsk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post TIPS/DIPS heart failure within first 6 months at ILBS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.