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

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ClinicalTrials.gov Identifier: NCT06050837
Recruitment Status : Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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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.


Condition or disease Intervention/treatment
High Risk Esophageal Varices Other: No intervention

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spleen Stiffness as a Measure to Assess the REsponse to β Blocker Therapy (SPARE-B).
Estimated Study Start Date : September 30, 2023
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    No intervention

Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the diagnostic accuracy of change in splenic stiffness to predict HVPG responders to beta-blockers at 4 weeks [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Change in Liver stiffness measurement [ Time Frame: 4 weeks ]
  2. Change in Fib-4, Fib-5 [ Time Frame: 4 weeks ]
  3. Change in vWF-antigen, VITRO [ Time Frame: 4 weeks ]
  4. Change in collagen markers - Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid [ Time Frame: 4 weeks ]
  5. To develop an AI based model to predict HVPG responders to beta blockers [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050837


Contacts
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Contact: Dr Omkar Rudra, MD 01146300000 omkar.rudra@gmail.com

Locations
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India
Institute of Liver & Biliary Sciences
New Delhi, Delhi, India, 110070
Contact: Dr Omkar Rudra, MD    01146300000    omkar.rudra@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT06050837    
Other Study ID Numbers: ILBS-SPARE-B-01
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Hypertension, Portal
Liver Diseases