Refractory AscitesNCT04050683
Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)
A study testing Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) in people with Refractory Ascites, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the vein above the collarbone in the neck) using fluoroscopy (real time x-rays) guidance. Then, a stent is inserted between the portal vein (vein that carries blood from the intestines into the liver) to a hepatic vein (vein that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Ascites
- What is being tested?
- Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
OVERALL INCLUSION
- ≥ 18 years
- Patients with indications as established by the ACR-SIR-SPR practice parameters::
- prophylaxis against recurrent variceal bleed in high-risk patients
- portal hypertensive gastropathy or intestine-opathy
- refractory ascites
- hepatic hydrothorax
- hepatopulmonary syndrome
- hepatorenal syndrome
- decompression of portosystemic collaterals prior to abdominal surgical procedures
- Technically successful creation of a TIPS shunt, defined as creation of a portosystemic shunt with post TIPS creation portosystemic gradient of ≤ 12 mmHg
STUDY ARM INCLUSION:
- All patients undergoing elective TIPS who meet at least one of the criteria:
- Right atrial pressure (RAP) ≥ 15mm Hg; OR
- Change in RAP ≥ 10mm Hg; OR
- Peak systolic velocity ratio (PSRV) pressure ≥ 46mm Hg
CONTROL ARM INCLUSION:
- Patients undergoing elective TIPS for control of refractory ascites who do not meet at least one of the criteria outlined above for the study arm.
Historical controls: we will use data collected form our own recent institutional review.
EXCLUSION All patients who do not exhibit alterations in invasive RAP or PRVS measurements as listed in Inclusion Criteria and do not meet criteria for participation as a control subject (i.e. are not undergoing elective TIPS for control of refractory ascites).
Admitted for GI bleed.
Budd-Chiari syndrome.
TIPS in setting of mesenteric vein thrombosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
About this study
During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the vein above the collarbone in the neck) using fluoroscopy (real time x-rays) guidance. Then, a stent is inserted between the portal vein (vein that carries blood from the intestines into the liver) to a hepatic vein (vein that carries blood away from the liver back to the heart). This means that blood that would usually gets filtered through the liver is now bypassing the liver and going directly to the heart. Because more blood will be flowing to the heart, the heart needs to be strong enough to handle the extra volume.
This study is being done to determine the impact of the TIPS procedure on cardiac (heart) function by collecting data (heart pressures) during the TIPS procedure. Immediately after TIPS and at standard follow-up time points, labs and transthoracic echocardiograms (TTE or echo) will also be collected.
The device(s) used in this study are neither the intervention studied nor the experimental variable of interest. Devices are commercially available and used, and procedures are performed, in accordance with the institution's standard of care.
Read the detailed description
The long-term goal of this proposal is to improve survival in patients with end stage liver disease following TIPS placement. Given that the most common indications for TIPS placement are also defining features of decompensated cirrhosis, specifically hemorrhage and refractory ascites, the overall health of this patient population is extraordinarily complex. One notable circulatory impact of cirrhosis is the increase in total blood volume in concert with a disproportionate increase in splanchnic blood volume. Therefore, at the time of TIPS placement, a patient may experience a marked increase in central blood volume that may lead to cardiac dysfunction. Considering that a central feature of cirrhotic cardiomyopathy is attenuated response to stress, it is conceivable that some perioperative cardiovascular complications could be attributed to the patient's baseline health rather than an isolated effect of the procedure alone. By instituting measures to identify patients that may be at increased risk for an adverse outcome, this proposal hopes to offer a new paradigm for managing TIPS patients in the acute postoperative setting. Therefore, the purpose of this study is to derive better correlates between non-invasive and invasive measurements of cardiac function.
- Conditions
- Refractory Ascites
- Being tested
- Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS), Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Keywords
- TIPS, Hemodynamic, Ascites, Hepatic, Hydrothorax
- Medical subject headings
- Ascites, Hydrothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)Procedure or surgery
Also called Hemodynamic Measurements, Transthoracic Echocardiogram (TTE), Research Blood Tests
Prior to and 1-3 days after the TIPS procedure, the following blood tests are done for research purposes: Brain Natriuretic Peptide (BNP); Endothelin-1; Tumor Necrosis Factor-alpha (TNF-a); Endothelial Nitric Oxide Synthase (eNOS). Subjects with abnormal heart pressures during TIPS will have a right heart catheterization (RHC) to monitor heart function, blood flow, and pressures in and around the heart. The subject will be admitted to the Cardiovascular Intensive Care Unit and have a TTE all of which are standard of care. Routine follow-up visits will occur in IR Clinic at 2 Weeks (± 3 days), 4-6 weeks and 4-6 months. Visits will include: blood draws for research related blood tests as listed above; standard of care ultrasound of the abdomen; TTEs; and for at least one year, routine lab testing, imaging, medications, and subject overall condition will be assessed for long term outcomes. Diagnostic RHC will be done as needed per standard of care.
Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)Procedure or surgery
Also called Hemodynamic Measurements, Research Blood Tests
Subject's with normal heart pressures who are having elective (planned in advance and not due to an emergency) TIPS due to refractory ascites (fluid build up in the belly that does not go away or comes back shortly after being removed). Prior to and 1-3 days after the TIPS procedure, the following blood tests are done for research purposes: Brain Natriuretic Peptide (BNP); Endothelin-1; Tumor Necrosis Factor-alpha (TNF-a); Endothelial Nitric Oxide Synthase (eNOS). The subject will be admitted to the hospital after TIPS for standard of care monitoring.
Routine follow-up visits will occur in IR Clinic at 2 Weeks (± 3 days), 4-6 weeks and 4-6 months. Visits will include: blood draws for research related blood tests as listed above; standard of care ultrasound of the abdomen; and for at least one year, routine lab testing, imaging, medications, and subject overall condition will be assessed for long term outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) | Experimental | Right Atrial Pressure (RAP) ≥ 15mmHg or change in RAP ≥ 10 mmHg or Peak Systolic Right Ventricular (PSRV) Pressure ≥ 46 mmHg Receives: Procedure: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
| Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) | Active comparator | Normal hemodynamic parameters Receives: Procedure: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac related events
any cardiac event to include, heart failure, heart attack, pulmonary hypertension
Measured: from insertion of TIPS to 1 year post TIPS
Secondary outcomes (4)
Clinical success
No further need for paracentesis or thoracentesis at 6 months
Measured: 6 months after TIPS placement
Overall survival
evaluation of overall survival from time of TIPS placement to death
Measured: all patients will be followed for 1 year after TIPS placement
Complications
Any peri or post procedural TIPS related events including liver failure, need for re-intervention, etc.
Measured: from insertion of TIPS to 1 year post TIPS
TIPS patency
evaluation of how long the TIPS remains patent without need for further intervention
Measured: from insertion of TIPS to 1 year post TIPS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start25 Sep 2019
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Refractory AscitesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All patients undergoing TIPS will have the following hemodynamic measurements obtained: systolic, diastolic and mean RAP; systolic, diastolic and mean right ventricular pressure (RSV). Peak systolic right ventricular (PSRV) pressure will serve as surrogate for pulmonary artery pressure (PAP). There are 2 groups in this project. Subjects will be enrolled in 1 of the 2 groups based on their heart pressure measurements (high or normal). If a subject does not meet criteria for 1 of the 2 groups, they will not be in the study.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Principal investigator, Eric J. Hohenwalter, Medical College of Wisconsin
- Investigators
- Eric J Hohenwalter, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050683
- Sponsor's protocol ID
- PRO 35079
- Status last verified
- Dec 2024
- First submitted
- 7 Aug 2019
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants must have agreed to banking of biosamples. Identified individual participant data for all primary and secondary outcome measures will be made available. Also, left-over research related blood samples will be retained in an IRB approved bank.
Publications
Colapinto RF, Stronell RD, Birch SJ, Langer B, Blendis LM, Greig PD, Gilas T. Creation of an intrahepatic portosystemic shunt with a Gruntzig balloon catheter. Can Med Assoc J. 1982 Feb 1;126(3):267-8. No abstract available.
PubMed 6977404ACR-SIR-SPR Practice Parameter for the Creation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS). :25.
Ascha M, Abuqayyas S, Hanouneh I, Alkukhun L, Sands M, Dweik RA, Tonelli AR. Predictors of mortality after transjugular portosystemic shunt. World J Hepatol. 2016 Apr 18;8(11):520-9. doi: 10.4254/wjh.v8.i11.520.
PubMed 27099653Parvinian A, Bui JT, Knuttinen MG, Minocha J, Gaba RC. Right atrial pressure may impact early survival of patients undergoing transjugular intrahepatic portosystemic shunt creation. Ann Hepatol. 2014 Jul-Aug;13(4):411-9.
PubMed 24927612Kiszka-Kanowitz M, Henriksen JH, Moller S, Bendtsen F. Blood volume distribution in patients with cirrhosis: aspects of the dual-head gamma-camera technique. J Hepatol. 2001 Nov;35(5):605-12. doi: 10.1016/s0168-8278(01)00175-1.
PubMed 11690706Xu J, Murphy SL, Kochanek KD, Bastian B, Arias E. Deaths: Final Data for 2016. Natl Vital Stat Rep. 2018 Jul;67(5):1-76.
PubMed 30248015Marcellin P, Kutala BK. Liver diseases: A major, neglected global public health problem requiring urgent actions and large-scale screening. Liver Int. 2018 Feb;38 Suppl 1:2-6. doi: 10.1111/liv.13682.
PubMed 29427496Liu H, Gaskari SA, Lee SS. Cardiac and vascular changes in cirrhosis: pathogenic mechanisms. World J Gastroenterol. 2006 Feb 14;12(6):837-42. doi: 10.3748/wjg.v12.i6.837.
PubMed 16521209Ruiz-del-Arbol L, Serradilla R. Cirrhotic cardiomyopathy. World J Gastroenterol. 2015 Nov 7;21(41):11502-21. doi: 10.3748/wjg.v21.i41.11502.
PubMed 26556983Luo B, Liu L, Tang L, Zhang J, Ling Y, Fallon MB. ET-1 and TNF-alpha in HPS: analysis in prehepatic portal hypertension and biliary and nonbiliary cirrhosis in rats. Am J Physiol Gastrointest Liver Physiol. 2004 Feb;286(2):G294-303. doi: 10.1152/ajpgi.00298.2003.
PubMed 14715521Tsiakalos A, Hatzis G, Moyssakis I, Karatzaferis A, Ziakas PD, Tzelepis GE. Portopulmonary hypertension and serum endothelin levels in hospitalized patients with cirrhosis. Hepatobiliary Pancreat Dis Int. 2011 Aug;10(4):393-8. doi: 10.1016/s1499-3872(11)60066-0.
PubMed 21813388Habash F, Gurram P, Almomani A, Duarte A, Hakeem A, Vallurupalli S, Bhatti S. Correlation between Echocardiographic Pulmonary Artery Pressure Estimates and Right Heart Catheterization Measurement in Liver Transplant Candidates. J Cardiovasc Imaging. 2018 Jun;26(2):75-84. doi: 10.4250/jcvi.2018.26.e2. Epub 2018 Jun 22.
PubMed 29971269Boyer TD, Haskal ZJ; American Association for the Study of Liver Diseases. The Role of Transjugular Intrahepatic Portosystemic Shunt (TIPS) in the Management of Portal Hypertension: update 2009. Hepatology. 2010 Jan;51(1):306. doi: 10.1002/hep.23383. No abstract available.
PubMed 19902484Hoeper MM, Krowka MJ, Strassburg CP. Portopulmonary hypertension and hepatopulmonary syndrome. Lancet. 2004 May 1;363(9419):1461-8. doi: 10.1016/S0140-6736(04)16107-2.
PubMed 15121411Ghaferi AA, Birkmeyer JD, Dimick JB. Complications, failure to rescue, and mortality with major inpatient surgery in medicare patients. Ann Surg. 2009 Dec;250(6):1029-34. doi: 10.1097/sla.0b013e3181bef697.
PubMed 19953723
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- ClinicalTrials.gov ID
- NCT04050683
- Acronym / sponsor ID
- PRO 35079
- Conditions
- Refractory Ascites
- Keywords
- TIPS, Hemodynamic, Ascites, Hepatic, Hydrothorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 8 Aug 2019 (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.
During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the vein above the collarbone in the neck) using fluoroscopy (real time x-rays) guidance. Then, a stent is inserted between the portal vein (vein that carries blood from the intestines into the liver) to a hepatic vein (vein that carries blood away from the liver back to the heart). This means that blood that would usually gets filtered through the liver is now bypassing the liver and going directly to the heart. Because more blood will be flowing to the heart, the heart needs to be strong enough to handle the extra volume.
This study is being done to determine the impact of the TIPS procedure on cardiac (heart) function by collecting data (heart pressures) during the TIPS procedure. Immediately after TIPS and at standard follow-up time points, labs and transthoracic echocardiograms (TTE or echo) will also be collected.
The device(s) used in this study are neither the intervention studied nor the experimental variable of interest. Devices are commercially available and used, and procedures are performed, in accordance with the institution's standard of care.
Detailed description
The long-term goal of this proposal is to improve survival in patients with end stage liver disease following TIPS placement. Given that the most common indications for TIPS placement are also defining features of decompensated cirrhosis, specifically hemorrhage and refractory ascites, the overall health of this patient population is extraordinarily complex. One notable circulatory impact of cirrhosis is the increase in total blood volume in concert with a disproportionate increase in splanchnic blood volume. Therefore, at the time of TIPS placement, a patient may experience a marked increase in central blood volume that may lead to cardiac dysfunction. Considering that a central feature of cirrhotic cardiomyopathy is attenuated response to stress, it is conceivable that some perioperative cardiovascular complications could be attributed to the patient's baseline health rather than an isolated effect of the procedure alone. By instituting measures to identify patients that may be at increased risk for an adverse outcome, this proposal hopes to offer a new paradigm for managing TIPS patients in the acute postoperative setting. Therefore, the purpose of this study is to derive better correlates between non-invasive and invasive measurements of cardiac function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients undergoing TIPS will have the following hemodynamic measurements obtained: systolic, diastolic and mean RAP; systolic, diastolic and mean right ventricular pressure (RSV). Peak systolic right ventricular (PSRV) pressure will serve as surrogate for pulmonary artery pressure (PAP). There are 2 groups in this project. Subjects will be enrolled in 1 of the 2 groups based on their heart pressure measurements (high or normal). If a subject does not meet criteria for 1 of the 2 groups, they will not be in the study.
| Arm | Type | Receives |
|---|---|---|
| Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) | Experimental | Procedure: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)Right Atrial Pressure (RAP) ≥ 15mmHg or change in RAP ≥ 10 mmHg or Peak Systolic Right Ventricular (PSRV) Pressure ≥ 46 mmHg |
| Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) | Active comparator | Procedure: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)Normal hemodynamic parameters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)Also: Hemodynamic Measurements, Transthoracic Echocardiogram (TTE), Research Blood TestsPrior to and 1-3 days after the TIPS procedure, the following blood tests are done for research purposes: Brain Natriuretic Peptide (BNP); Endothelin-1; Tumor Necrosis Factor-alpha (TNF-a); Endothelial Nitric Oxide Synthase (eNOS). Subjects with abnormal heart pressures during TIPS will have a right heart catheterization (RHC) to monitor heart function, blood flow, and pressures in and around the heart. The subject will be admitted to the Cardiovascular Intensive Care Unit and have a TTE all of which are standard of care. Routine follow-up visits will occur in IR Clinic at 2 Weeks (± 3 days), 4-6 weeks and 4-6 months. Visits will include: blood draws for research related blood tests as listed above; standard of care ultrasound of the abdomen; TTEs; and for at least one year, routine lab testing, imaging, medications, and subject overall condition will be assessed for long term outcomes. Diagnostic RHC will be done as needed per standard of care. | Procedure or surgery | Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
| Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)Also: Hemodynamic Measurements, Research Blood TestsSubject's with normal heart pressures who are having elective (planned in advance and not due to an emergency) TIPS due to refractory ascites (fluid build up in the belly that does not go away or comes back shortly after being removed). Prior to and 1-3 days after the TIPS procedure, the following blood tests are done for research purposes: Brain Natriuretic Peptide (BNP); Endothelin-1; Tumor Necrosis Factor-alpha (TNF-a); Endothelial Nitric Oxide Synthase (eNOS). The subject will be admitted to the hospital after TIPS for standard of care monitoring. Routine follow-up visits will occur in IR Clinic at 2 Weeks (± 3 days), 4-6 weeks and 4-6 months. Visits will include: blood draws for research related blood tests as listed above; standard of care ultrasound of the abdomen; and for at least one year, routine lab testing, imaging, medications, and subject overall condition will be assessed for long term outcomes. | Procedure or surgery | Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
Primary outcome
Cardiac related events
Time frame: from insertion of TIPS to 1 year post TIPS
any cardiac event to include, heart failure, heart attack, pulmonary hypertension
4 secondary outcomes
Clinical success
Time frame: 6 months after TIPS placement
Overall survival
Time frame: all patients will be followed for 1 year after TIPS placement
Complications
Time frame: from insertion of TIPS to 1 year post TIPS
TIPS patency
Time frame: from insertion of TIPS to 1 year post TIPS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Background: PubMed 6977404Colapinto RF, Stronell RD, Birch SJ, Langer B, Blendis LM, Greig PD, Gilas T. Creation of an intrahepatic portosystemic shunt with a Gruntzig balloon catheter. Can Med Assoc J. 1982 Feb 1;126(3):267-8. No abstract available.
- BackgroundACR-SIR-SPR Practice Parameter for the Creation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS). :25.
- Background: PubMed 27099653Ascha M, Abuqayyas S, Hanouneh I, Alkukhun L, Sands M, Dweik RA, Tonelli AR. Predictors of mortality after transjugular portosystemic shunt. World J Hepatol. 2016 Apr 18;8(11):520-9. doi: 10.4254/wjh.v8.i11.520.
- Background: PubMed 24927612Parvinian A, Bui JT, Knuttinen MG, Minocha J, Gaba RC. Right atrial pressure may impact early survival of patients undergoing transjugular intrahepatic portosystemic shunt creation. Ann Hepatol. 2014 Jul-Aug;13(4):411-9.
- Background: PubMed 11690706Kiszka-Kanowitz M, Henriksen JH, Moller S, Bendtsen F. Blood volume distribution in patients with cirrhosis: aspects of the dual-head gamma-camera technique. J Hepatol. 2001 Nov;35(5):605-12. doi: 10.1016/s0168-8278(01)00175-1.
- Background: PubMed 30248015Xu J, Murphy SL, Kochanek KD, Bastian B, Arias E. Deaths: Final Data for 2016. Natl Vital Stat Rep. 2018 Jul;67(5):1-76.
- Background: PubMed 29427496Marcellin P, Kutala BK. Liver diseases: A major, neglected global public health problem requiring urgent actions and large-scale screening. Liver Int. 2018 Feb;38 Suppl 1:2-6. doi: 10.1111/liv.13682.
- Background: PubMed 16521209Liu H, Gaskari SA, Lee SS. Cardiac and vascular changes in cirrhosis: pathogenic mechanisms. World J Gastroenterol. 2006 Feb 14;12(6):837-42. doi: 10.3748/wjg.v12.i6.837.
- Background: PubMed 26556983Ruiz-del-Arbol L, Serradilla R. Cirrhotic cardiomyopathy. World J Gastroenterol. 2015 Nov 7;21(41):11502-21. doi: 10.3748/wjg.v21.i41.11502.
- Background: PubMed 14715521Luo B, Liu L, Tang L, Zhang J, Ling Y, Fallon MB. ET-1 and TNF-alpha in HPS: analysis in prehepatic portal hypertension and biliary and nonbiliary cirrhosis in rats. Am J Physiol Gastrointest Liver Physiol. 2004 Feb;286(2):G294-303. doi: 10.1152/ajpgi.00298.2003.
- Background: PubMed 21813388Tsiakalos A, Hatzis G, Moyssakis I, Karatzaferis A, Ziakas PD, Tzelepis GE. Portopulmonary hypertension and serum endothelin levels in hospitalized patients with cirrhosis. Hepatobiliary Pancreat Dis Int. 2011 Aug;10(4):393-8. doi: 10.1016/s1499-3872(11)60066-0.
- Background: PubMed 29971269Habash F, Gurram P, Almomani A, Duarte A, Hakeem A, Vallurupalli S, Bhatti S. Correlation between Echocardiographic Pulmonary Artery Pressure Estimates and Right Heart Catheterization Measurement in Liver Transplant Candidates. J Cardiovasc Imaging. 2018 Jun;26(2):75-84. doi: 10.4250/jcvi.2018.26.e2. Epub 2018 Jun 22.
- Individual participant dataSharing planned: Yes. Participants must have agreed to banking of biosamples. Identified individual participant data for all primary and secondary outcome measures will be made available. Also, left-over research related blood samples will be retained in an IRB approved bank.
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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. This study is not recruiting at the moment.
Eric J Hohenwalter, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) in people with Refractory Ascites, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 13 Dec 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac related events (time frame: from insertion of TIPS to 1 year post TIPS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04050683, which also lists 18 linked publications.
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 13 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.