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Carvedilol(beta blockers) to prevent decompensation in patient with compensated advanced chronic liver disease. A randomized controlled trial.

Carvedilol to prevent decompensation in patients with compensated advanced chronic liver disease without high risk varices with liver stiffness more than 20kPa : An open label randomised controlled trial - CaLD-20 trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044878
Enrollment
268
Registered
2022-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K74- Fibrosis and cirrhosis of liver

Interventions

Intervention1: Tablet Carvedilol: tablet carvedilol initiated at the dose of 6.25mg/day orally, gradually dose increased by 3.125 mg every 2 weeks to maximum tolerable dose, maximum dose of 25mg per d

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with compensated advance chronic liver disease(cACLD) of non-viral etiologies with a LSM >20 kPa without HRVs on Endoscopy. 2.For HCV related ACLD, those with LSM >20KpA despite achieving sustained virological response at week-12 after treatment. 3.All patients of cACLD with LRVs on EGD.

Exclusion criteria

Exclusion criteria: 1) Cirrhosis with clinical decompensations 2) cACLD with HRVs on EGD 3) Patients with LSM 4) cACLD with isolated gastric varices 5) HCV related cACLD on direct acting antivirals 6) cACLD with HCC or portal venous thrombosis 7) cACLD with large porto-systemic shunts ( >10mm) 8) Alcoholic hepatitis 9) Pregnancy and lactation 10) Previous use of beta-blockers in last 3 months 11) Contraindication for beta-blockers 12) Unwilling to participate 13) Non-cirrhotic portal hypertension

Design outcomes

Primary

MeasureTime frame
Cumulative rates of all cause clinical decompensation such as onset of clinical asicites, episode of variceal bleed and episode of hepatic enceplopathy after randomization to either armTimepoint: 3 months, 6 months and 12 months—

Secondary

MeasureTime frame
a) All-cause and liver related mortality in both arms. b) Progression of of small varices to large varices c) Development of new varices in patients with no varices d) Incidence of individual decompensation in both arms at such as ascites, HE, SBP ,variceal bleeding and ACLF, any renal dysfunction as per ICA-AKI classification e) Adverse events related to treatment f) Quality of life using EQ-5D-5L questionnaire. Timepoint: 6 months and 12 months—

Countries

India

Contacts

Public ContactANOOP SARAYA

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

ansaraya@yahoo.com9868397203

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026