Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients - "ACT - C ACLF Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298656
• Other study ID #: ILBS-ACLF-17
• Status: Not yet recruiting
• Start date: March 10, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: February 2024
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Garvit Mundra, MD
• Phone: 01146300000
• Email: garvitmundrailbs[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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) 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

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:

1. Baseline characteristics:

2. History and etiology of liver disease

3. Symptomatology, Evidence of decompensation (jaundice, encephalopathy, ascites, infections, variceal bleed etc)

4. Clinical and demographic profile

5. Endoscopy

Stopping rule of study:

1. Progression to exclusion criteria

2. In case of hypotension(<90/60mmHg) or Heart Rate <60 after carvedilol

3. Potential liver transplant within 90 days

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age 18-70 yrs

2. ACLF diagnosis (AARC criteria)

Exclusion Criteria:

1. Contraindications to NSBB (Heart rate < 65 /min, BP < 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na < 125meq/l)

2. PVT

3. HCC

4. BCS

5. HE grades 2-4

6. NSBB therapy within 5 days

7. Pregnancy

8. Lactation

9. Planned for LT in the next 12 weeks

10. No consent.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

Other:
• No intervention
It is an observational study.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences (ILBS)	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF		28 days
Secondary	Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days		90 days
Secondary	Transplant-free survival rate at 90 days		90 days
Secondary	Correlation with evolution of AARC score by 2 week		2 week