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

Cirrhosis With Esophageal Varices Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465645
• Other study ID #: ILBS-Cirrhosis-004
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: January 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All patients of chronic liver disease with esophageal varices.

2. Age more than and equal to 18 years.

Exclusion Criteria:

1. Patients of chronic liver disease with history of upper Gastro Intestinal bleed.

2. Patients of acute on chronic liver failure

3. Thrombosis of splenoportal axis

4. Hepatocellular carcinoma

5. Patients who were on primary variceal ligation sessions as prophylaxis

6. Patients who are beta blocker intolerant (Prior h/o hypotension, bradycardia).

7. 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)}.

8. Failure to give consent for inclusion in the study

Related Conditions & MeSH terms

• Cirrhosis With Esophageal Varices
• Esophageal and Gastric Varices
• Hypertension
• Hypertension, Portal
• Varicose Veins

Intervention

Drug:
• Carvedilol

• Carvedilol + Simvastatin

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of patients who will be Responders.	Responders (Absolute value of HVPG<12 mm Hg or HVPG=20% reduction)	3 Months
Secondary	Total number of patients develop esophageal variceal bleed		3 months
Secondary	Total number of patients develop PHG (Portal Hypertensive Gastropathy).		3 months
Secondary	Total number of patients develop GAVE (Gastric Antral Vascular Ectasia).		3 months
Secondary	Total number of patients develop Gastric Varices.		3 months
Secondary	Total number of patients develop adverse Events of the study drug		3 months
Secondary	Improvement in the CTP (Child-Turcotte-Pugh score) score.		3 months
Secondary	Improvement in the MELD (Model for End Stage liver Disease) score.		3 months