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Hypertension, PortalNCT03713606

Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

An observational study of Hypertension, Portal, run by Nanfang Hospital, Southern Medical University at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, multi-center diagnostic trial conducted at 6 liver centers in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and hepatic venous pressure gradient in cirrhosis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension, Portal
What is being tested?
HVPG measurement
Type of treatment
Surgery or procedure
How many people
75 participants
Where
6 sitesChina
Study dates
30 Sep 2018to 1 Jun 2022
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Cirrhotic portal hypertension

Who may be able to join

  • age 18-75 years;
  • confirmed cirrhosis based on histologic examination of liver or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver.

Who cannot join

  • prior drug therapy (e.g. β-blocker, vasopressin) within two weeks
  • prior surgeries (e.g. TIPS, partial splenic embolization/ devascularization, splenectomy, liver transplantation)
  • non-sinusoidal portal hypertension \& HCC inability to adhere to study procedures
  • pregnancy or unknown pregnancy status
  • no informed consent

Trial locations and contacts

6 sites in 1 country.

Xiaolong Qi, M.D. contact

+86 18588602600

qixiaolong@vip.163.com

Yanna Liu contact

+86 15625076784

lauyenna@126.com

6 sites in 1 country

China6 sites, 6 recruiting

  • 302 Hospital of PLA

    Beijing

    Ruizhao Qi, MD

    Ruizhao Qi, MD

    Recruiting

  • Beijing Friendship Hospital

    Beijing

    Yu Wang, MD

    Yu Wang, MD

    Recruiting

  • Beijing Shijitan Hospital

    Beijing

    Fuquan Liu, MD

    Fuquan Liu, MD

    Recruiting

  • Beijing YouAn Hospital

    Beijing

    Huiguo Ding, MD

    Huiguo Ding, MD

    Recruiting

  • Shandong Provincial Hospital

    Jinan

    Chunqing Zhang, MD

    Chunqing Zhang, MD

    Recruiting

  • Xingtai People's Hospital

    Xingtai

    Dengxiang Liu, MD

    Dengxiang Liu, MD

    Recruiting

Other trials in China

About this study

Official title: Serum Biomarkers Associated With Endothelial Dysfunction and Immune Inflammation for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

This is a prospective, multi-center diagnostic trial conducted at 6 liver centers in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and hepatic venous pressure gradient in cirrhosis.

Read the detailed description

Hepatic venous pressure gradient (HVPG) is the gold standard for assessing portal pressure, of which the measurement is invasive and therefore not suitable for routine clinical practice. The detection of serum biomarkers is potential for noninvasive diagnosis of portal hypertension in cirrhosis. However, many are still in the exploratory phases of testing and are not yet ready to enter clinical practice. This study prospectively enrolled participants in 6 liver centers (Beijing YouAn Hospital, Shandong Provincial Hospital, Beijing Shijitan Hospital, Beijing Friendship Hospital, Xingtai People's Hospital, and 302 Hospital of PLA) in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and HVPG in cirrhosis.

Being tested
HVPG measurement
Keywords
Portal hypertension, serum biomarker, diagnosis
Medical subject headings
Hypertension, Portal, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HVPG measurementProcedure or surgery

    Also called Blood test

    HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.

Study groups in NCT03713606
Study groupRoleWhat they receive
Overall eligible participantsEligible participants will receive HVPG measurement by catheterization of a hepatic vein with a balloon catheter and run blood tests.
Receives: Procedure: HVPG measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between serum biomarkers and HVPG

    Correlation between serum biomarkers and HVPG

    Measured: 1 day

Secondary outcomes (1)

  1. Correlation between serum biomarkers and HVPG in HBV subgroup

    Correlation between serum biomarkers and HVPG in a subgroup of patients with HBV-related cirrhosis

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2018
  2. Study start30 Sep 2018
  3. Primary completion31 Jan 2022 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Resources

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
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03713606
Sponsor's protocol ID
Pan-CHESS1802
Status last verified
Aug 2021
First submitted
18 Oct 2018
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided.

Publications

  • Groszmann RJ, Wongcharatrawee S. The hepatic venous pressure gradient: anything worth doing should be done right. Hepatology. 2004 Feb;39(2):280-2. doi: 10.1002/hep.20062. No abstract available.

    PubMed 14767976

  • Waidmann O, Brunner F, Herrmann E, Zeuzem S, Piiper A, Kronenberger B. Macrophage activation is a prognostic parameter for variceal bleeding and overall survival in patients with liver cirrhosis. J Hepatol. 2013 May;58(5):956-61. doi: 10.1016/j.jhep.2013.01.005. Epub 2013 Jan 16.

    PubMed 23333526

  • Buck M, Garcia-Tsao G, Groszmann RJ, Stalling C, Grace ND, Burroughs AK, Patch D, Matloff DS, Clopton P, Chojkier M. Novel inflammatory biomarkers of portal pressure in compensated cirrhosis patients. Hepatology. 2014 Mar;59(3):1052-9. doi: 10.1002/hep.26755. Epub 2014 Jan 29.

    PubMed 24115225

  • Ferlitsch M, Reiberger T, Hoke M, Salzl P, Schwengerer B, Ulbrich G, Payer BA, Trauner M, Peck-Radosavljevic M, Ferlitsch A. von Willebrand factor as new noninvasive predictor of portal hypertension, decompensation and mortality in patients with liver cirrhosis. Hepatology. 2012 Oct;56(4):1439-47. doi: 10.1002/hep.25806. Epub 2012 Aug 27.

    PubMed 22532296

  • Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.

    PubMed 30215362

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, Portal, run by Nanfang Hospital, Southern Medical University at 6 sites 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 2 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 Xiaolong Qi, M.D. (+86 18588602600, qixiaolong@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between serum biomarkers and HVPG (time frame: 1 day). 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 NCT03713606, which also lists 5 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 17 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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