Acute-On-Chronic Liver FailureNCT06298656
Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients
An observational study of Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Clinically significant portal hypertension (CSPH) is defined as HVPG >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 10 Mar 2024to 28 Feb 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria
Who may be able to join
- Age 18-70 yrs
- ACLF diagnosis (AARC criteria)
Who cannot join
- Contraindications to NSBB (Heart rate < 65 /min, BP < 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na < 125meq/l)
- PVT
- HCC
- BCS
- HE grades 2-4
- NSBB therapy within 5 days
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- Pregnancy
- Lactation
- Planned for LT in the next 12 weeks
- No consent.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Garvit Mundra, MD, 01146300000, garvitmundrailbs@gmail.com
About this study
Official title: Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients - "ACT - C ACLF Study
Clinically significant portal hypertension (CSPH) is defined as HVPG >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to <12 mm Hg or reduction to >20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study
Read the detailed description
To assess whether Acute hemodynamic response to oral Carvedilol can predict short term outcome in ACLF patients.
- To determine the best cut off to define acute hemodynamic response in ACLF patients
Primary outcome - Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF
Secondary outcome -
(1) Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days (2) Transplant-free survival rate at 90 days (3) Correlation with evolution of AARC score by 2 week
(b) Methodology
Study population: Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria
Baseline parameters that will be recorded:
- Baseline characteristics:
- History and etiology of liver disease
- Symptomatology, Evidence of decompensation (jaundice, encephalopathy, ascites, infections, variceal bleed etc)
- Clinical and demographic profile
- Endoscopy
Stopping rule of study:
- Progression to exclusion criteria
- In case of hypotension(<90/60mmHg) or Heart Rate <60 after carvedilol
- Potential liver transplant within 90 days
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- No intervention
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
It is an observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF
Measured: 28 days
Secondary outcomes (3)
Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days
Measured: 90 days
Transplant-free survival rate at 90 days
Measured: 90 days
Correlation with evolution of AARC score by 2 week
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start10 Mar 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298656
- Sponsor's protocol ID
- ILBS-ACLF-17
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2024
- Last updated
- 7 Mar 2024
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients - "ACT - C ACLF Study
- ClinicalTrials.gov ID
- NCT06298656
- Acronym / sponsor ID
- ILBS-ACLF-17
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 7 Mar 2024 (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.
Clinically significant portal hypertension (CSPH) is defined as HVPG >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to <12 mm Hg or reduction to >20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study
Detailed description
To assess whether Acute hemodynamic response to oral Carvedilol can predict short term outcome in ACLF patients.
- To determine the best cut off to define acute hemodynamic response in ACLF patients
Primary outcome - Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF
Secondary outcome -
(1) Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days (2) Transplant-free survival rate at 90 days (3) Correlation with evolution of AARC score by 2 week
(b) Methodology
Study population: Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria
Baseline parameters that will be recorded:
- Baseline characteristics:
- History and etiology of liver disease
- Symptomatology, Evidence of decompensation (jaundice, encephalopathy, ascites, infections, variceal bleed etc)
- Clinical and demographic profile
- Endoscopy
Stopping rule of study:
- Progression to exclusion criteria
- In case of hypotension(<90/60mmHg) or Heart Rate <60 after carvedilol
- Potential liver transplant within 90 days
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- Age 18-70 yrs
- ACLF diagnosis (AARC criteria)
Key exclusion criteria (10 listed)
- Contraindications to NSBB (Heart rate < 65 /min, BP < 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na < 125meq/l)
- PVT
- HCC
- BCS
- HE grades 2-4
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 |
|---|---|---|
| No interventionIt is an observational study. | Other | – |
Primary outcome
Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF
Time frame: 28 days
3 secondary outcomes
Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days
Time frame: 90 days
Transplant-free survival rate at 90 days
Time frame: 90 days
Correlation with evolution of AARC score by 2 week
Time frame: 2 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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 Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 10 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 7 Mar 2024. 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 India. 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 Dr Garvit Mundra, MD (01146300000, garvitmundrailbs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF (time frame: 28 days). 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 7 Mar 2024.