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OpenTrials
Completed

NCT Number: NCT02465645

To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.

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.

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Key information

Conditions

Cirrhosis With Esophageal Varices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)}.
  • Failure to give consent for inclusion in the study

Treatment and study plan

Carvedilol

Drug

Carvedilol + Simvastatin

Drug

Primary outcomes

  1. Total number of patients who will be Responders.

    Time frame: 3 Months

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

Secondary outcomes

  1. Total number of patients develop esophageal variceal bleed

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

  4. Total number of patients develop Gastric Varices.

    Time frame: 3 months

  5. Total number of patients develop adverse Events of the study drug

    Time frame: 3 months

  6. Improvement in the CTP (Child-Turcotte-Pugh score) score.

    Time frame: 3 months

  7. Improvement in the MELD (Model for End Stage liver Disease) score.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

A Prospective Randomized Study to Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2015
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.