Portosystemic ShuntNCT07481877
Portosystemic Shunt-associated Pulmonary Hypertension Multi-center Prospective Cohort Study
An observational study of Portosystemic Shunt and Pulmonary Hypertension, run by Chinese Pulmonary Vascular Disease Research Group.
Trial summary
This study aims to establish a multi-center registry cohort of portosystemic shunt-associated pulmonary hypertension, with the goal of clarifying the epidemiology, clinical features, phenotypic classification, response to targeted therapy, and prognostic outcomes in patients with portosystemic shunt-associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portosystemic Shunt, Pulmonary Hypertension
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2031
- 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: patients with portosystemic shunt-associated pulmonary hypertension
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of Portosystemic Shunts:Imaging evidence suggestive of portosystemic shunts (congenital or acquired) or unequivocal clinical signs of portal hypertension (e.g., splenomegaly, varices).
- Diagnosis of Pulmonary Hypertension (PH):
- Confirmed by Right Heart Catheterization (RHC): mPAP > 20 mmHg; OR
- Highly suspected by Echocardiography: Peak TRV > 3.4 m/s or compliant with ESC/ERS guidelines for high probability of PH (Note: RHC is encouraged for all enrolled patients).
- Signed informed consent and willingness to strictly adhere to the follow-up schedule.
Who cannot join
- PH caused by other reasons
- Hepatocellular carcinoma (HCC) exceeding the Milan criteria.
- Active extrahepatic malignancy.
- Transjugular intrahepatic portosystemic shunt (TIPS) placement within the previous month.
- Pregnancy or lactation.
- Participation in other interventional clinical trials (drug or device) within the last 3 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to establish a multi-center registry cohort of portosystemic shunt-associated pulmonary hypertension, with the goal of clarifying the epidemiology, clinical features, phenotypic classification, response to targeted therapy, and prognostic outcomes in patients with portosystemic shunt-associated pulmonary hypertension.
Read the detailed description
Portosystemic shunt-associated pulmonary hypertension is defined as a condition of abnormal pulmonary hemodynamics resulting from congenital or acquired portosystemic shunts. This clinical entity is common and presents with highly heterogeneous hemodynamic profiles, including pulmonary arterial hypertension, post-capillary pulmonary hypertension, and high-output pulmonary hypertension. Currently, no dedicated cohorts exist for this specific population, and targeted clinical data are lacking. Even for portopulmonary hypertension (PoPH), a more extensively studied subtype, previous studies in East Asian populations have primarily relied on small, single-center retrospective cohorts. Therefore, this study aims to establish a multi-center registry cohort of portosystemic shunt-associated pulmonary hypertension, with the goal of clarifying the epidemiology, clinical features, phenotypic classification, response to targeted therapy, and prognostic outcomes, thereby providing an evidence-based foundation for developing tailored diagnostic and therapeutic strategies for this population.
- Conditions
- Portosystemic Shunt, Pulmonary Hypertension
- Keywords
- Portosystemic Shunt, Pulmonary Hypertension, POPH, Portal hypertension, Cirrhosis
- Medical subject headings
- Hypertension, Pulmonary, Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Portosystemic shunt-associated pulmonary hypertension | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical worsening
The rate of clinical worsening during the follow-up period, which is a composite endpoint comprising all-cause death, decline in exercise capacity [defined as a ≥15% reduction in 6-minute walk distance (6MWD) compared with baseline], deterioration in World Health Organization (WHO) functional class, and non-elective hospitalizations for pulmonary hypertension (due to worsening heart failure or initiation of parenteral prostanoids).
Measured: Up to 24 months
Secondary outcomes (4)
Change from baseline in model for End-Stage Liver Disease (MELD) score
The MELD score is a reliable measure of mortality risk in patients with end-stage liver disease, calculated using serum bilirubin, serum creatinine, and the international normalized ratio (INR). The total score ranges from 6 to 40. Higher scores indicate more severe hepatic impairment and worse prognosis in patients with portosystemic shunt-associated pulmonary hypertension. The change in MELD score from baseline will be evaluated at each specified follow-up visit.
Measured: Baseline, Month 12, and Month 24
Change from baseline in Child-Pugh Score
The Child-Pugh score assesses the severity and prognosis of chronic liver disease based on five clinical measures: total bilirubin, serum albumin, prothrombin time (INR), ascites, and hepatic encephalopathy. The total score ranges from 5 to 15, where 5-6 indicates Class A (well-compensated), 7-9 indicates Class B (significant functional compromise), and 10-15 indicates Class C (decompensated). Higher scores represent worse liver function. The change in the total Child-Pugh score from baseline will be reported.
Measured: Baseline, Month 12, and Month 24
Listing for or receipt of liver transplant or lung transplant
This measure assesses the time elapsed from study enrollment to the first documented occurrence of a transplant-related event due to the progression of portosystemic shunt-associated pulmonary hypertension. A transplant-related event is strictly defined as either being officially placed on an active waiting list for a liver or lung transplant, or the actual surgical receipt of a liver or lung transplant. The time to whichever event occurs first will be recorded.
Measured: Up to 24 months
Initiation or escalation of oral pulmonary hypertension (PH)-targeted therapy
This measure assesses the time elapsed from study enrollment to the first documented initiation or escalation of oral targeted therapy for portosystemic shunt-associated pulmonary hypertension. "Initiation or escalation" is strictly defined as the sequential addition of a new class of oral PH-targeted medication. This encompasses the clinical transition from no PH therapy to oral monotherapy, from monotherapy to double combination therapy, or from double to triple combination therapy. Dose increases of pre-existing oral medications are excluded from this definition.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portosystemic ShuntStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481877
- Sponsor's protocol ID
- PROSPECT
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 19 Mar 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portosystemic Shunt-associated Pulmonary Hypertension Multi-center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07481877
- Acronym / sponsor ID
- PROSPECT
- Conditions
- Portosystemic Shunt, Pulmonary Hypertension
- Keywords
- Portosystemic Shunt, Pulmonary Hypertension, POPH, Portal hypertension, Cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 19 Mar 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.
This study aims to establish a multi-center registry cohort of portosystemic shunt-associated pulmonary hypertension, with the goal of clarifying the epidemiology, clinical features, phenotypic classification, response to targeted therapy, and prognostic outcomes in patients with portosystemic shunt-associated pulmonary hypertension.
Detailed description
Portosystemic shunt-associated pulmonary hypertension is defined as a condition of abnormal pulmonary hemodynamics resulting from congenital or acquired portosystemic shunts. This clinical entity is common and presents with highly heterogeneous hemodynamic profiles, including pulmonary arterial hypertension, post-capillary pulmonary hypertension, and high-output pulmonary hypertension. Currently, no dedicated cohorts exist for this specific population, and targeted clinical data are lacking. Even for portopulmonary hypertension (PoPH), a more extensively studied subtype, previous studies in East Asian populations have primarily relied on small, single-center retrospective cohorts. Therefore, this study aims to establish a multi-center registry cohort of portosystemic shunt-associated pulmonary hypertension, with the goal of clarifying the epidemiology, clinical features, phenotypic classification, response to targeted therapy, and prognostic outcomes, thereby providing an evidence-based foundation for developing tailored diagnostic and therapeutic strategies for this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portosystemic shunt-associated pulmonary hypertension | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with portosystemic shunt-associated pulmonary hypertension
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Diagnosis of Portosystemic Shunts:Imaging evidence suggestive of portosystemic shunts (congenital or acquired) or unequivocal clinical signs of portal hypertension (e.g., splenomegaly, varices).
- Diagnosis of Pulmonary Hypertension (PH):
- Signed informed consent and willingness to strictly adhere to the follow-up schedule.
Key exclusion criteria (6 listed)
- PH caused by other reasons
- Hepatocellular carcinoma (HCC) exceeding the Milan criteria.
- Active extrahepatic malignancy.
- Transjugular intrahepatic portosystemic shunt (TIPS) placement within the previous month.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical worsening
Time frame: Up to 24 months
The rate of clinical worsening during the follow-up period, which is a composite endpoint comprising all-cause death, decline in exercise capacity [defined as a ≥15% reduction in 6-minute walk distance (6MWD) compared with baseline], deterioration in World Health Organization (WHO) functional class, and non-elective hospitalizations for pulmonary hypertension (due to worsening heart failure or initiation of parenteral prostanoids).
4 secondary outcomes
Change from baseline in model for End-Stage Liver Disease (MELD) score
Time frame: Baseline, Month 12, and Month 24
Change from baseline in Child-Pugh Score
Time frame: Baseline, Month 12, and Month 24
Listing for or receipt of liver transplant or lung transplant
Time frame: Up to 24 months
Initiation or escalation of oral pulmonary hypertension (PH)-targeted therapy
Time frame: Up to 24 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 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Portosystemic Shunt
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Recruiting
Periinterventional Coagulation Management of Patients Undergoing a TIPS
Liver Cirrhosis
RecruitingObservational study
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Ascites, Variceal Bleeding
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Portosystemic Shunt and Pulmonary Hypertension, run by Chinese Pulmonary Vascular Disease Research Group.
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 6 inclusion and 6 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 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Zhihong Liu, MD, PhD (+86 13269276067, zhihongliufuwai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical worsening (time frame: Up to 24 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 Mar 2026.