Portal HypertensionNCT04820166
The Effect of Monitoring PVP on Clinical Outcomes in Patients With PH
An observational study of Portal Hypertension, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. The level of portal venous pressure is closely related to the prognosis of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- monitoring portal pressure gradient or hepatic venous pressure gradient
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2021to 31 Dec 2025
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: patients with portal hypertension
Who may be able to join
- With chronic liver disease
- Age 18-80 years
- Patients who require a portal pressure measurement at the discretion of the treating physician
- Voluntarily signed informed consent
Who cannot join
- With serious cardiopulmonary disease or other diseases affect survival
- With severe renal dysfunction
- Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis
- Women who are planning to become pregnant or who are pregnant or breastfeeding
- The researcher judged that it was not suitable to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong
Xiaofeng Zhang, 1282614092@qq.com
About this study
Official title: The Effect of Monitoring Portal Venous Pressure on Clinical Outcomes in Patients With Portal Hypertension: a Prospective, Single-center, Observational Study
The complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. The level of portal venous pressure is closely related to the prognosis of patients. HVPG (hepatic venous pressure gradient) is the "gold standard" for predicting portal venous pressure and an important indicator for evaluating the efficacy of NSBBS. However, monitoring HVPG has many limitations，and the clinical application is also limited to a certain extent. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. At the same time, to explore the correlation between HVPG and PPG in cirrhosis patients at different stages and different etiologies, and to evaluate the role of spleen stiffness in predicting the severity of esophageal and gastric varices in patients with portal hypertension, and to find biomarkers to predict the risk of complications related to portal hypertension.
- Conditions
- Portal Hypertension
- Being tested
- monitoring portal pressure gradient or hepatic venous pressure gradient
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring portal pressure gradient or hepatic venous pressure gradientOther
measuring portal pressure gradient or hepatic venous pressure gradient regularly
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroesophageal varices bleeding
Patients with gastroesophageal varices has hematemesis or melena, and active bleeding or red sign can be seen under endoscopy
Measured: three years
Ascites
Peritoneal effusion was seen under ultrasound
Measured: three years
Hepatic encephalopathy
Patients with altered consciousness or unresponsiveness, accompanied by elevated blood ammonia
Measured: three years
Secondary outcomes (1)
Death or final follow-up time (3 years)
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start12 Mar 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820166
- Sponsor's protocol ID
- NFEC-2021-062
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu M, Zhang X, Cheng X, He Q, Zhou T, Wang H, Li B, Luo W, Li J, Li H, Lin Z, Song J, Wang W, Huang J, Ji Y, Zhou D, Xie W, Yang Q, Tu M, Luo X, Zhang X, Yan H, Chen J. Indocyanine Green Clearance Test via Pulse Dye Densitometry for Portal Hypertension Diagnosis in cACLD. Liver Int. 2025 Dec;45(12):e70425. doi: 10.1111/liv.70425.
PubMed 41178521Zhang X, Zhou L, Liang W, Cheng X, He Q, Li H, Luo W, Huang J, Li J, Wang W, Tu M, Wang H, Ou P, Wen B, Xiao L, Zhou D, Wong VW, Chen J. Identification of Clinically Significant Portal Hypertension in cACLD Individuals With Spleen Stiffness Measurement. Liver Int. 2025 Apr;45(4):e16241. doi: 10.1111/liv.16241.
PubMed 40105356
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Monitoring Portal Venous Pressure on Clinical Outcomes in Patients With Portal Hypertension: a Prospective, Single-center, Observational Study
- ClinicalTrials.gov ID
- NCT04820166
- Acronym / sponsor ID
- NFEC-2021-062
- Conditions
- Portal Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Mar 2021 (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 complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. The level of portal venous pressure is closely related to the prognosis of patients. HVPG (hepatic venous pressure gradient) is the "gold standard" for predicting portal venous pressure and an important indicator for evaluating the efficacy of NSBBS. However, monitoring HVPG has many limitations，and the clinical application is also limited to a certain extent. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. At the same time, to explore the correlation between HVPG and PPG in cirrhosis patients at different stages and different etiologies, and to evaluate the role of spleen stiffness in predicting the severity of esophageal and gastric varices in patients with portal hypertension, and to find biomarkers to predict the risk of complications related to portal hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with portal hypertension
Key inclusion criteria (4 listed)
- With chronic liver disease
- Age 18-80 years
- Patients who require a portal pressure measurement at the discretion of the treating physician
- Voluntarily signed informed consent
Key exclusion criteria (5 listed)
- With serious cardiopulmonary disease or other diseases affect survival
- With severe renal dysfunction
- Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis
- Women who are planning to become pregnant or who are pregnant or breastfeeding
- The researcher judged that it was not suitable to participate in this study
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 |
|---|---|---|
| monitoring portal pressure gradient or hepatic venous pressure gradientmeasuring portal pressure gradient or hepatic venous pressure gradient regularly | Other | – |
Primary outcome
Gastroesophageal varices bleeding
Time frame: three years
Patients with gastroesophageal varices has hematemesis or melena, and active bleeding or red sign can be seen under endoscopy
Ascites
Time frame: three years
Peritoneal effusion was seen under ultrasound
Hepatic encephalopathy
Time frame: three years
Patients with altered consciousness or unresponsiveness, accompanied by elevated blood ammonia
1 secondary outcome
Death or final follow-up time (3 years)
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Derived from this study: PubMed 41178521Liu M, Zhang X, Cheng X, He Q, Zhou T, Wang H, Li B, Luo W, Li J, Li H, Lin Z, Song J, Wang W, Huang J, Ji Y, Zhou D, Xie W, Yang Q, Tu M, Luo X, Zhang X, Yan H, Chen J. Indocyanine Green Clearance Test via Pulse Dye Densitometry for Portal Hypertension Diagnosis in cACLD. Liver Int. 2025 Dec;45(12):e70425. doi: 10.1111/liv.70425.
- Derived from this study: PubMed 40105356Zhang X, Zhou L, Liang W, Cheng X, He Q, Li H, Luo W, Huang J, Li J, Wang W, Tu M, Wang H, Ou P, Wen B, Xiao L, Zhou D, Wong VW, Chen J. Identification of Clinically Significant Portal Hypertension in cACLD Individuals With Spleen Stiffness Measurement. Liver Int. 2025 Apr;45(4):e16241. doi: 10.1111/liv.16241.
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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.
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 Nanfang Hospital, Southern Medical University at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Mar 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaofeng Zhang (+8618565552050, 1282614092@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroesophageal varices bleeding (time frame: three years). The study lists 3 primary outcomes in all. 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 NCT04820166, which also lists 2 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 29 Mar 2021.