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

NCT ID: NCT06050837

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-08-31

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.

Detailed Description

Aim and Objective: To evaluate change in splenic stiffness measurement as a surrogate for response to non-selective beta blockers in patients with high-risk esophageal varices.

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

• 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.

• Study design - Single center, Prospective, observational study.
• Study period - 1 year
• Sample size - We are enrolling 130 patients in the study
• Intervention - Carvedilol will be initiated to all patients with high-risk esophageal varices (in the absence of any contraindications) at a dose of 3.125mg BD and titrated to the maximum tolerable dose within 7 days.
• Monitoring and assessment -
• Investigations - performed at Baseline

1. CBC, RFT, LFT, PT/INR, vWF-Ag, HbA1c

2. Collagen markers: Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid

3. ECG

4. 2D Echocardiography

5. CECT Whole Abdomen

6. Splenic stiffness measurement

7. Liver stiffness measurement

8. Upper GI endoscopy

9. HVPG

• Investigations - performed at 1 month of maximum tolerable dose of Carvedilol

1. CBC, RFT, LFT, PT/INR, vWF-Ag

2. Collagen markers: Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid

3. ECG

4. Splenic stiffness measurement

5. Liver stiffness measurement

6. HVPG

• Adverse effects (of carvedilol)

1. Allergy

2. Light headedness

3. Exercise intolerance

4. Fatigue

5. Chest tightness

Stopping rule - Development of variceal bleed

Expected outcome of the project:

Change in splenic stiffness will correlates with change in HVPG and can reliably predict response to non-selective beta blockers in patient with high-risk esophageal varices.

Conditions

High Risk Esophageal Varices

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility 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

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 :

1. Heart rate < 50 bpm

2. Systolic BP < 100 mm Hg

3. Severe COPD

4. Atrioventricular block

5. Known PVD

6. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Central Contacts

Dr Omkar Rudra, MD

Role: CONTACT

omkar.rudra@gmail.com

01146300000

Facility Contacts

Dr Omkar Rudra, MD

Role: primary

omkar.rudra@gmail.com

01146300000

Other Identifiers

ILBS-SPARE-B-01

Identifier Type: -

Identifier Source: org_study_id