Portal HypertensionNCT02356250
A Pilot Study: Defining Peripheral Endothelial Function in Portal Hypertensive Cirrhotic Patients
An observational study of Portal Hypertension and Cirrhosis, run by Eyal Ashkenazi.
Trial summary
Rationale for the study: To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation between HVPG ( hepatic vein pressure gradient ) result and PEF result in a way that the result of the PEF test will be able to predict if a patient has CSPH (yes of no). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension, Cirrhosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Feb 2015to 29 Nov 2016
- 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: A maximum of 30 patients with cirrhosis Ages between 18 to 75
Who may be able to join
- > 18 years old (Male/Female) and not more than 75 years old
- Diagnosis of cirrhosis:
- By liver biopsy ii. Or strong suspicion of cirrhosis by accepted criteria for the clinical diagnosis of cirrhosis (e.g. peripheral edema or varices, palpable hard left lobe of the liver, small right lobe span or palpable splenomegaly), and/or radiological evidence of cirrhosis (by abdominal US, CT, or MRI, showing a nodular liver and/or portosystemic collaterals with portal vein patency and/or ascites and/or splenomegaly, and/or colloid shift on a colloid-isotope liver-spleen scan), and/or laboratory variables (platelets <100,000/mm3, albumin< 3.5g/dL, or INR >1.3) and/or presence of esophageal varices (without previous variceal bleeding episode) or HVPG≥12mmHg from previous testing, or by FIbroscan or Fibrotest results showing fibrosis stage- 4.
- Has been scheduled for hemodynamic study testing. d. Patients should have a Child Pugh score A or higher
Who cannot join
- Patients already receiving beta blockers
- Hepatocellular carcinoma
- Portal vein thrombosis
- Cholestatic liver disease
- Severe heart, pulmonary or renal disease.
- Patients with Ischemic heart disease
Show all 17Show fewer
- Patients with diabetes mellitus
- Any major surgery in the past 3 months.
- Patient is a recipient of any organ transplant
- Patient, based on the opinion of the investigator, should not be enrolled into this study.
- Patients unable or unwilling to sign informed consent
- Patients that are participating in other clinical trials evaluating experimental treatments or procedures or have participated in a clinical trial in the past 3 months.
- Active smoking
- Uncontrolled hypertension
- Withdrawal criteria:
- Patient that based on the opinion of the investigator should be withdrawl from the study due to no compliance
- Patient wish to stop participate in study.
About this study
Official title: A Pilot Study: Defining Peripheral Endothelial Function in Portal Hypertensive
Rationale for the study:
To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation between HVPG ( hepatic vein pressure gradient ) result and PEF result in a way that the result of the PEF test will be able to predict if a patient has CSPH (yes of no). By this, to try and develop a portable office-based device that can produce immediate results in a non-invasive manner in cirrhotic patients and help in evaluating prognosis in these patients in a noninvasive manner.
Read more
Aim:
The aim of this study is to try and characterize the peripheral endothelial function (PEF) in patient with cirrhosis and CSPH. This will be evaluated by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study.
Read the detailed description
To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation between HVPG result and PEF result in a way that the result of the PEF test will be able to predict if a patient has CSPH (yes of no). By this, to try and develop a portable office-based device that can produce immediate results in a non-invasive manner in cirrhotic patients and help in evaluating prognosis in these patients in a noninvasive manner
- Conditions
- Portal Hypertension, Cirrhosis
- Keywords
- liver biopsy f 4
- Medical subject headings
- 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 |
|---|---|---|
| PORTAL HYPERTENSION | PAIEBT WITH PORTAL HYPERTENSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
is to try and characterize the peripheral endothelial function (PEF) in patient with cirrhosis and CSPH (by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study)
by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study
Measured: 2 month for each patient and 1 year total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study start18 Feb 2015
- Primary completion29 Nov 2016
- Study completion29 Nov 2016
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyal Ashkenazi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eyal Ashkenazi, Carmel Medical Center
- Investigators
- EYAL ASHKENAZI, DR, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356250
- Sponsor's protocol ID
- CMC 14-0117-CTIL
- Status last verified
- Jul 2018
- First submitted
- 25 Jan 2015
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Defining Peripheral Endothelial Function in Portal Hypertensive
- ClinicalTrials.gov ID
- NCT02356250
- Acronym / sponsor ID
- CMC 14-0117-CTIL
- Conditions
- Portal Hypertension, Cirrhosis
- Keywords
- liver biopsy f 4
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eyal AshkenaziUniversity, hospital or other
- Study start
- 18 Feb 2015 (actual)
- Primary completion
- 29 Nov 2016 (actual)
- Study completion
- 29 Nov 2016 (actual)
- First posted
- 5 Feb 2015 (estimated)
- 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.
Rationale for the study:
To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation between HVPG ( hepatic vein pressure gradient ) result and PEF result in a way that the result of the PEF test will be able to predict if a patient has CSPH (yes of no). By this, to try and develop a portable office-based device that can produce immediate results in a non-invasive manner in cirrhotic patients and help in evaluating prognosis in these patients in a noninvasive manner.
Aim:
The aim of this study is to try and characterize the peripheral endothelial function (PEF) in patient with cirrhosis and CSPH. This will be evaluated by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study.
Detailed description
To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation between HVPG result and PEF result in a way that the result of the PEF test will be able to predict if a patient has CSPH (yes of no). By this, to try and develop a portable office-based device that can produce immediate results in a non-invasive manner in cirrhotic patients and help in evaluating prognosis in these patients in a noninvasive manner
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PORTAL HYPERTENSION | – | –PAIEBT WITH PORTAL HYPERTENSION |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A maximum of 30 patients with cirrhosis Ages between 18 to 75
Key inclusion criteria (4 listed)
- > 18 years old (Male/Female) and not more than 75 years old
- Diagnosis of cirrhosis:
- By liver biopsy ii. Or strong suspicion of cirrhosis by accepted criteria for the clinical diagnosis of cirrhosis (e.g. peripheral edema or varices, palpable hard left lobe of the liver, small right lobe span or palpable splenomegaly), and/or radiological evidence of cirrhosis (by abdominal US, CT, or MRI, showing a nodular liver and/or portosystemic collaterals with portal vein patency and/or ascites and/or splenomegaly, and/or colloid shift on a colloid-isotope liver-spleen scan), and/or laboratory variables (platelets <100,000/mm3, albumin< 3.5g/dL, or INR >1.3) and/or presence of esophageal varices (without previous variceal bleeding episode) or HVPG≥12mmHg from previous testing, or by FIbroscan or Fibrotest results showing fibrosis stage- 4.
- Has been scheduled for hemodynamic study testing. d. Patients should have a Child Pugh score A or higher
Key exclusion criteria (17 listed)
- Patients already receiving beta blockers
- Hepatocellular carcinoma
- Portal vein thrombosis
- Cholestatic liver disease
- Severe heart, pulmonary or renal disease.
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
is to try and characterize the peripheral endothelial function (PEF) in patient with cirrhosis and CSPH (by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study)
Time frame: 2 month for each patient and 1 year total
by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
EYAL ASHKENAZI, DR principal investigator
Carmel Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension and Cirrhosis, run by Eyal Ashkenazi.
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 17 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: withdrawn, as of the sponsor's last update on 26 Jul 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
is to try and characterize the peripheral endothelial function (PEF) in patient with cirrhosis and CSPH (by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study) (time frame: 2 month for each patient and 1 year total). 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 26 Jul 2018.