Spleen Stiffness as a Measure to Assess the REsponse to β Blocker Therapy (SPARE-B)

NCT06050837 | Unknown

• 1 other identifier: ILBS-SPARE-B-01
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

HVPG is the gold standard for measurement of the presence and severity of portal hypertension. Clinically Significant Portal Hypertension (CSPH) is defined as HVPG ≥ 10 mmHg. Reducing the HVPG by use of non-selective beta blockers has been associated with reduced risk of variceal hemorrhage, ascites, SBP and thus has a positive effect on survival. Response to Beta blocker therapy is defined as a reduction of HVPG by 10% or to ≤ 12 mmHg. HVPG is an invasive method of assessment of portal pressures, with lack of availability at many centres. While non-invasive tests to predict CSPH have been defined, predicting response to beta-blockers non-invasively is an unmet clinical need. The aim of this study is to use splenic stiffness measurement, a non-invasive test, as a surrogate to assess the response of HVPG to beta blocker therapy.

Conditions

High Risk Esophageal Varices

Outcome Measures

Primary Outcomes (1)

• To evaluate the diagnostic accuracy of change in splenic stiffness to predict HVPG responders to beta-blockers at 4 weeks

  4 weeks

Secondary Outcomes (5)

• Change in Liver stiffness measurement

  4 weeks

• Change in Fib-4, Fib-5

  4 weeks

• Change in vWF-antigen, VITRO

  4 weeks

• Change in collagen markers - Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid

  4 weeks

• To develop an AI based model to predict HVPG responders to beta blockers

  4 weeks

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged ≥ 18 years and ≤ 70 years presenting to Institute of Liver and Biliary Sciences, New Delhi with high-risk esophageal varices upon presentation and are giving written consent for participation in the study.

You may qualify if:

• Age ≥ 18 years
• Cirrhosis of liver of different etiologies, with evidence of high-risk esophageal varices
• Alcohol abstinence for 3 months
• Written informed consent

You may not qualify if:

• Age ≥ 70 years
• Previous or imminent variceal ligation
• Non Cirrhotic Portal Hypertension
• Portal vein, splenic vein thrombosis
• Porto-systemic shunts \> 10 mm
• Patients already on beta blockers
• Contraindications to beta blocker therapy :
• Heart rate \< 50 bpm
• Systolic BP \< 100 mm Hg
• Severe COPD
• Atrioventricular block
• Known PVD
• Poor control of T2DM (HbA1c\>9)
• Technical difficulties for splenic stiffness measurement
• Cardio-pulmonary disorders

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Central Study Contacts

Dr Omkar Rudra, MD

CONTACT

01146300000; omkar.rudra@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 22, 2023
• Study Start: September 30, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)