NCT02465645

Brief Summary

After successful screening of patients based on inclusion criteria, we will measure the baseline Hepatic Venous Pressure Gradient. At day 1 patients will undergo complete blood investigation including complete haemogram, kidney function test, liver function test, prothrombin time, AFP (Alfa Feto Protein) level, chest x ray, ultrasonography, fibroscan. Routine complete physical examination will be done.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

May 11, 2018

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

June 4, 2015

Last Update Submit

May 10, 2018

Conditions

Cirrhosis With Esophageal Varices

Outcome Measures

Primary Outcomes (1)

  • Total number of patients who will be Responders.

    Responders (Absolute value of HVPG\<12 mm Hg or HVPG≥20% reduction)

    3 Months

Secondary Outcomes (7)

  • Total number of patients develop esophageal variceal bleed

    3 months

  • Total number of patients develop PHG (Portal Hypertensive Gastropathy).

    3 months

  • Total number of patients develop GAVE (Gastric Antral Vascular Ectasia).

    3 months

  • Total number of patients develop Gastric Varices.

    3 months

  • Total number of patients develop adverse Events of the study drug

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Carvedilol + Simvastatin

EXPERIMENTAL

Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min. Simvastatin will be administered orally at a start dose of 20 mg for 15 days followed by 40 mg OD for the next 3 months. Along with Simvastatin, Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.

Drug: Carvedilol + Simvastatin

Carvedilol

ACTIVE COMPARATOR

Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.

Drug: Carvedilol

Interventions

CarvedilolDRUG
Carvedilol
Carvedilol + SimvastatinDRUG
Carvedilol + Simvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients of chronic liver disease with esophageal varices.
  • Age more than and equal to 18 years.

You may not qualify if:

  • Patients of chronic liver disease with history of upper Gastro Intestinal bleed.
  • Patients of acute on chronic liver failure
  • Thrombosis of splenoportal axis
  • Hepatocellular carcinoma
  • Patients who were on primary variceal ligation sessions as prophylaxis
  • Patients who are beta blocker intolerant (Prior h/o hypotension, bradycardia).
  • Patients who are contraindicated for beta blockers {H/O COPD (Coronary Obstructive Pulmonary Disease), heart block, refractory Ascites, SBP(Spontaneous Bacterial Peritonitis) , HRS(Hepato Renal Syndrome)}.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

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

Location

Related Publications (1)

  • Vijayaraghavan R, Jindal A, Arora V, Choudhary A, Kumar G, Sarin SK. Hemodynamic Effects of Adding Simvastatin to Carvedilol for Primary Prophylaxis of Variceal Bleeding: A Randomized Controlled Trial. Am J Gastroenterol. 2020 May;115(5):729-737. doi: 10.14309/ajg.0000000000000551.

    PMID: 32079861DERIVED

MeSH Terms

Interventions

CarvedilolSimvastatin

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Dr V Rajan, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 8, 2015

Study Start

June 1, 2015

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

May 11, 2018

Record last verified: 2017-01

Locations

IN(1)