A prospective study to evaluate the long-term effect of carvedilol versus propranolol on reduction in portal pressure in cirrhotic patients

A Randomized, Multi-center, Phase IV Open-label Study to Evaluate the Long-term Effect of Carvedilol versus Propranolol on Reduction in Portal Pressure in Patients with Cirrhosis

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000102

Enrollment

130

Registered

2011-03-02

Start date

2011-07-12

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : carvedilol 6.25 mg/day~increasing the dose up to 12.5 mg/day at intervals of 1-2 weeks for 6 weeks propranolol 40mg/day~maximum 320mg/day (resting heart rate is reduced by 25% or is less than 5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) cirrhosis (2) severe portal hypertension (hepatic venous pressure gradient > 12mmHg) (3) F2/F3 varices or endoscopic treatment of large esophageal varices at least 3 months old the last time (4) Child-Pugh score < 12 (5) not taking patients beta-blocker, ACE inhibitor, nitrate within 1 month

Exclusion criteria

Exclusion criteria: (1) systolic blood pressure 10 mg/dL (8) srum creatinine = 1.2 mg/dL (9) history of shunt or TIPS (10) IDDM (11) pregnancy (12) allergy to beta-blocker or alpha-blocker (13) unwilling to sign inform consent (14) Clinical investigator have determined that patient is difficult to perform the clinical trial.

Design outcomes

Primary

Measure	Time frame
reduction of hepatic pressure gradient	—

Secondary

Measure	Time frame
compliance;incidence of variceal bleeding;the relationship between hepatic venous pressure gradinet and ultrasonographic findings	—

Countries

Korea, Republic of

Contacts

Public ContactTae Yeob Kim

Hanyang University Guri Hospital

Outcome results