Clinical trial NCT03736265: Carvedilol for Prevention of Esophageal Varices Progression
Official title: Clinical Study of Carvedilol for the Prevention of the Progression of Esophageal Varices in Hepatitis B Related Cirrhotic Patients With Anti-Viral Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis, Liver
Portal Hypertension
Keywords: Portal Hypertension
Esophageal varices
Carvedilol
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

Brief summary: Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear.

Detailed description: It has been concluded 40%-70% of chronic hepatitis B patients can achieve fibrosis/ cirrhosis reversion after effective anti-viral therapy. But there is still some patients progress to decompensation. Esophageal varices are the main complication of cirrhotic patients. Propranolol are widely used to prevent variceal bleeding in patients with large esophageal varices. It has been shown the efficacy of propranolol in the preventing of the progression from small to large varices reported no effect. Recently, carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear. The purpose of this study is to demonstrate the efficacy of carvedilol in the preventing of the progression from small to large varices in hepatitis B patients.

Eligibility criteria: Inclusion Criteria:

* Male or Female;
* HBV-related liver cirrhotic patients with at least two years of antiviral therapy;
* The presence of small or medium esophageal varices without red color sign;
* HBV-DNA\<1×10E3 IU/ml
* Signature of informed consent

Exclusion Criteria:

* Previous presence of decompensated cirrhosis including ascites, bleeding and HE (hepatic encephalopathy);
* Any contra-indications to beta-blockers including asthma, chronic obstructive pulmonary disease, allergic rhinitis, NYHA (New York Heart Association) class IV heart failure, atrioventricular block, sinus bradycardia (HR \< 50 bpm), cardiogenic shock, hypotension (SBP \< 90 mmHg), sick sinus syndrome, insulin dependent diabetes, peripheral vascular disease.
* Allergic to Carvedilol;
* Any malignancy that affects survival；
* Renal dysfunction；
* History of beta-blockers within last 3 months；
* History of surgery for portal hypertension；History of prior EVL (endoscopic variceal ligation) or sclerotherapy, history of surgery for portal hypertension including portosystemic shunts, disconnection and spleen resection and transjugular intrahepatic portosystemic shunt；
* Severe systemic diseases；
* Refusal to participate in the study.

Primary outcomes:
measure: The progression Incidence of esophageal varices.
timeFrame: 2 years
Secondary outcomes:
measure: The incidence of liver cirrhosis decompensation
timeFrame: 2 years
measure: The incidence of hepatic cellular carcinoma, death or liver transplantation.
timeFrame: 2 years
measure: The progression rate of non-invasive scores (Child-Pugh、MELD、APRI、FIB-4 score).
timeFrame: 2 years
measure: The dynamic change of liver stiffness quantified by transient elastography.
timeFrame: 2 years
measure: The dynamic change of hemodynamics parameter
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: The First Affiliated Hospital of Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Beijing Friendship Hospital
name: Xiaojuan Ou
role: PRINCIPAL_INVESTIGATOR
References: