Portal HypertensionNEPTUN2NCT04393519
Non-invasive Evaluation Program for TIPS and Follow Up Network 2 (NEPTUN2)
An observational study of Portal Hypertension, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- TIPS procedure
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 12 May 2020to 31 Dec 2030
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients receiving TIPS according to guidelines
Who may be able to join
- Insertion of TIPS according to guidelines
Who cannot join
- Contraindication for TIPS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn
Michael Praktiknjo, MD, +49228 28715770, michael.praktiknjo@ukbonn.de
Johannes Chang, MD, +49228 28715770, johannes.chang@ukbonn.de
About this study
Official title: Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol 2
Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.
Read the detailed description
NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.
- Conditions
- Portal Hypertension
- Being tested
- TIPS procedure
- Keywords
- transjugular intrahepatic portosystemic shunt (TIPS), non-invasive assessments, Transthoracic echocardiography (TTE) with Speckle-tracking, Computer tomography scan (CT-scan), Magnetic resonance imaging (MRI), Circulating biomarkers, Electroencephalography (EEG), Elastography
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPS procedureDevice
Implantation of TIPS for portal hypertension
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Prospective cohort that received TIPS from 05/12/2020 onwards Receives: Device: TIPS procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
death, liver transplantation
Measured: up to 10 years
Secondary outcomes (9)
Ascites
Evaluation of amount of ascites according to the Child-Score (0=none;1=moderate/treatable; 2=severe/refractory)
Measured: up to 10 years
Hepatic Encephalopathy (HE)
Evaluation of the grade according to the West Haven Criteria (Grade 0 (no HE) - Grade 4 (hepatic coma))
Measured: up to 10 years
Variceal Bleeding
Assessment of presence of variceal bleeding
Measured: up to 10 years
Liver Failure
defined as Bilirubin level ≥ 12mg/dl
Measured: up to 10 years
Acute-on-Chronic Liver Failure (ACLF)
Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria
Measured: up to 10 years
Organ Failures
Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score (Score 6 (best) to 18 (worst))
Measured: up to 10 years
Kidney Failure
Assessment of AKI according to KDIGO definition
Measured: up to 10 years
Sarcopenia
Assessment of sarcopenia according to EASL-guideline definition
Measured: up to 10 years
post-surgical survival
Assessment of post-surgical survival
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start12 May 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Praktiknjo, University Hospital, Bonn
- Investigators
- Michael Praktiknjo, MD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393519
- Sponsor's protocol ID
- NEPTUN2
- Acronym
- NEPTUN2
- Status last verified
- Oct 2021
- First submitted
- 12 May 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heger LA, Chang J, Rohrer C, Reincke M, Eyth A, Sturm L, Schultheiss M, Maier A, Meyer C, Jansen C, Graf K, Ozturk C, Schneider F, Trebicka J, Westermann D, Thimme R, Grundmann S, Praktiknjo M, Bettinger D. Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt. Liver Int. 2025 Dec;45(12):e70422. doi: 10.1111/liv.70422.
PubMed 41204773
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol 2
- ClinicalTrials.gov ID
- NCT04393519
- Acronym / sponsor ID
- NEPTUN2 / NEPTUN2
- Conditions
- Portal Hypertension
- Keywords
- transjugular intrahepatic portosystemic shunt (TIPS), non-invasive assessments, Transthoracic echocardiography (TTE) with Speckle-tracking, Computer tomography scan (CT-scan), Magnetic resonance imaging (MRI), Circulating biomarkers, Electroencephalography (EEG), Elastography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 May 2020 (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.
Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.
Detailed description
NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Device: TIPS procedureProspective cohort that received TIPS from 05/12/2020 onwards |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving TIPS according to guidelines
Key inclusion criteria (1 listed)
- Insertion of TIPS according to guidelines
Key exclusion criteria (1 listed)
- Contraindication for TIPS
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 |
|---|---|---|
| TIPS procedureImplantation of TIPS for portal hypertension | Device | Prospective |
Primary outcome
Survival
Time frame: up to 10 years
death, liver transplantation
9 secondary outcomes
Ascites
Time frame: up to 10 years
Hepatic Encephalopathy (HE)
Time frame: up to 10 years
Variceal Bleeding
Time frame: up to 10 years
Liver Failure
Time frame: up to 10 years
Acute-on-Chronic Liver Failure (ACLF)
Time frame: up to 10 years
Organ Failures
Time frame: up to 10 years
Kidney Failure
Time frame: up to 10 years
Sarcopenia
Time frame: up to 10 years
post-surgical survival
Time frame: up to 10 years
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 5 Oct 2021.
- Derived from this study: PubMed 41204773Heger LA, Chang J, Rohrer C, Reincke M, Eyth A, Sturm L, Schultheiss M, Maier A, Meyer C, Jansen C, Graf K, Ozturk C, Schneider F, Trebicka J, Westermann D, Thimme R, Grundmann S, Praktiknjo M, Bettinger D. Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt. Liver Int. 2025 Dec;45(12):e70422. doi: 10.1111/liv.70422.
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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.
Michael Praktiknjo, MD principal investigator
University of Bonn
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 Portal Hypertension, run by University Hospital, Bonn at 1 site in Germany.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Oct 2021. 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 Germany. 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 Michael Praktiknjo, MD (+49(0)228-287 15770, michael.praktiknjo@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: up to 10 years). 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 NCT04393519, which also lists 1 linked publication.
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 5 Oct 2021.