High Risk Esophageal VaricesNCT06050837
Spleen Stiffness as a Measure to Assess the REsponse to β Blocker Therapy (SPARE-B)
An observational study of High Risk Esophageal Varices, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- High Risk Esophageal Varices
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- 30 Sep 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years
- Cirrhosis of liver of different etiologies, with evidence of high-risk esophageal varices
- Alcohol abstinence for 3 months
- Written informed consent
Who cannot join
- 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
Show all 23Show fewer
- 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
- Budd Chiari Syndrome
- Grade 3 ascites
- Acute Kidney Injury or Chronic Kidney Disease
- Severely Obese patients (BMI > 40)
- Pregnant women
- Advanced HCC
- Psychiatric Illness
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Omkar Rudra, MD, 01146300000, omkar.rudra@gmail.com
About this study
Official title: Spleen Stiffness as a Measure to Assess the REsponse to β Blocker Therapy (SPARE-B).
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.
Read the 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
- CBC, RFT, LFT, PT/INR, vWF-Ag, HbA1c
- Collagen markers: Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid
- ECG
- 2D Echocardiography
- CECT Whole Abdomen
- Splenic stiffness measurement
- Liver stiffness measurement
- Upper GI endoscopy
- HVPG
- Investigations - performed at 1 month of maximum tolerable dose of Carvedilol
- CBC, RFT, LFT, PT/INR, vWF-Ag
- Collagen markers: Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid
- ECG
- Splenic stiffness measurement
- Liver stiffness measurement
- HVPG
- Adverse effects (of carvedilol)
- Allergy
- Light headedness
- Exercise intolerance
- Fatigue
- 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
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the diagnostic accuracy of change in splenic stiffness to predict HVPG responders to beta-blockers at 4 weeks
Measured: 4 weeks
Secondary outcomes (5)
Change in Liver stiffness measurement
Measured: 4 weeks
Change in Fib-4, Fib-5
Measured: 4 weeks
Change in vWF-antigen, VITRO
Measured: 4 weeks
Change in collagen markers - Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid
Measured: 4 weeks
To develop an AI based model to predict HVPG responders to beta blockers
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start30 Sep 2023 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050837
- Sponsor's protocol ID
- ILBS-SPARE-B-01
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spleen Stiffness as a Measure to Assess the REsponse to β Blocker Therapy (SPARE-B).
- ClinicalTrials.gov ID
- NCT06050837
- Acronym / sponsor ID
- ILBS-SPARE-B-01
- Conditions
- High Risk Esophageal Varices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- CBC, RFT, LFT, PT/INR, vWF-Ag, HbA1c
- Collagen markers: Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid
- ECG
- 2D Echocardiography
- CECT Whole Abdomen
- Splenic stiffness measurement
- Liver stiffness measurement
- Upper GI endoscopy
- HVPG
- Investigations - performed at 1 month of maximum tolerable dose of Carvedilol
- CBC, RFT, LFT, PT/INR, vWF-Ag
- Collagen markers: Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid
- ECG
- Splenic stiffness measurement
- Liver stiffness measurement
- HVPG
- Adverse effects (of carvedilol)
- Allergy
- Light headedness
- Exercise intolerance
- Fatigue
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Cirrhosis of liver of different etiologies, with evidence of high-risk esophageal varices
- Alcohol abstinence for 3 months
- Written informed consent
Key exclusion criteria (23 listed)
- Age ≥ 70 years
- Previous or imminent variceal ligation
- Non Cirrhotic Portal Hypertension
- Portal vein, splenic vein thrombosis
- Porto-systemic shunts > 10 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
To evaluate the diagnostic accuracy of change in splenic stiffness to predict HVPG responders to beta-blockers at 4 weeks
Time frame: 4 weeks
5 secondary outcomes
Change in Liver stiffness measurement
Time frame: 4 weeks
Change in Fib-4, Fib-5
Time frame: 4 weeks
Change in vWF-antigen, VITRO
Time frame: 4 weeks
Change in collagen markers - Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acid
Time frame: 4 weeks
To develop an AI based model to predict HVPG responders to beta blockers
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk Esophageal Varices, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Omkar Rudra, MD (01146300000, omkar.rudra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the diagnostic accuracy of change in splenic stiffness to predict HVPG responders to beta-blockers at 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.