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Change in splenic stiffness measurement as a marker of response to beta blocker therapy

Spleen Stiffness as a Measure to Assess the Response to ß Blocker Therapy (SPARE-B). - SPARE-B

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058264
Enrollment
130
Registered
2023-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: K768- Other specified diseases of liver

Interventions

Intervention1: NIL: NIL

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Cirrhosis of liver of different etiologies, with evidence of high-risk esophageal varices 3. Alcohol abstinence for 3 months 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Age = 70 years 2. Previous or imminent variceal ligation 3. Non Cirrhotic Portal Hypertension 4. Portal vein, splenic vein thrombosis 5. Porto-systemic shunts > 10 mm 6. Patients already on beta blockers 7. Contraindications to beta blocker therapy : a. Heart rate b. Systolic SBP c. Severe COPD d. Atrioventricular block e. Known PVD f. Poor control of T2DM (HbA1c >9) 8. Technical difficulties for splenic stiffness measurement 9. Cardio-pulmonary disorders 10. Budd Chiari Syndrome 11. Grade 3 ascites 12. Acute Kidney Injury or Chronic Kidney Disease 13. Severely Obese patients (BMI > 40) 14. Pregnant women 15. Advanced HCC 16. Psychiatric Illness 17. Lack of informed consent

Design outcomes

Primary

MeasureTime frame
To evaluate the diagnostic accuracy of change in splenic stiffness to predict HVPG responders to beta-blockers at 4 weeksTimepoint: 4 weeks—

Secondary

MeasureTime frame
Change in collagen markers - Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acidTimepoint: 4 weeks;Change in Fib-4, Fib-5Timepoint: 4 weeks;Change in Liver stiffness measurementTimepoint: 4 weeks;Change in vWF-antigen, VITROTimepoint: 4 weeks;To develop an AI based model to predict HVPG responders to beta blockersTimepoint: 4 weeks—

Countries

India

Contacts

Public ContactDr Manoj Kumar Sharma

Institute of Liver and Biliary Sciences

manojkumardm@gmail.com01146300000

Outcome results

None listed

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