Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 81 of 228 for:    EDN1

Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04050683
Recruitment Status : Enrolling by invitation
First Posted : August 8, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Radiological Society of North America
Information provided by (Responsible Party):
Eric J. Hohenwalter, Medical College of Wisconsin

Brief 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 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.


Condition or disease Intervention/treatment Phase
Refractory Ascites Procedure: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: 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
Procedure: Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Prior to and 24-72 hours 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 for a minimum of 24 hours 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.
Other Names:
  • Hemodynamic Measurements
  • Transthoracic Echocardiogram (TTE)
  • Research Blood Tests

Active Comparator: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Normal hemodynamic parameters
Procedure: Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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 24-72 hours 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 24 hour 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. A research related TTE will be done at the 4-6 week visit.

Other Names:
  • Hemodynamic Measurements
  • Research Blood Tests




Primary Outcome Measures :
  1. Cardiac related events [ Time Frame: from insertion of TIPS to 2 years post TIPS ]
    any cardiac event to include, heart failure, heart attack, pulmonary hypertension


Secondary Outcome Measures :
  1. Clinical success [ Time Frame: 6 months after TIPS placement ]
    No further need for paracentesis or thoracentesis at 6 months

  2. Overall survival [ Time Frame: all patients will be followed for 2 years after TIPS placement ]
    evaluation of overall survival from time of TIPS placement to death

  3. Complications [ Time Frame: from insertion of TIPS to 2 years post TIPS ]
    Any peri or post procedural TIPS related events including liver failure, need for re-intervention, etc.

  4. TIPS patency [ Time Frame: from insertion of TIPS to 2 years post TIPS ]
    evaluation of how long the TIPS remains patent without need for further intervention


Other Outcome Measures:
  1. Correlation of cardiac events with laboratory values [ Time Frame: labs will be obtained at baseline and post TIPS at 24 hours, 4-6 weeks, and 4-6 months ]
    correlations will be made between outcome BNP, TNF-a, eNOS, endothelin-1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

OVERALL INCUSION

  • ≥ 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050683


Locations
Layout table for location information
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Radiological Society of North America
Investigators
Layout table for investigator information
Principal Investigator: Eric J Hohenwalter, MD Medical College of Wisconsin

Additional Information:
Publications:
ACR-SIR-SPR Practice Parameter for the Creation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS). :25.
National Vital Statistics Reports Volume 67, Number 5 July 26, 2018, Deaths: Final Data for 2016. :76.

Layout table for additonal information
Responsible Party: Eric J. Hohenwalter, MD, Professor of Radiology, Vascular & Interventional Radiology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04050683     History of Changes
Other Study ID Numbers: PRO 35079
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: During and after (indefinitely) study participation.
Access Criteria: Participants must have signed the biosample bank consent.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eric J. Hohenwalter, Medical College of Wisconsin:
TIPS
Hemodynamic
Ascites
Hepatic
Hydrothorax
Additional relevant MeSH terms:
Layout table for MeSH terms
Ascites
Pathologic Processes