The Effects of Carvedilol in Patients with Severe Portal Hypertension with Non-response to Propranolol
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000624
- Lead Sponsor
- Hanyang University Guri Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
(1) nonrresponder to propranolol used in patients enrolled A Randomized, Multi-center, Phase IV Open-label Study (Cris KCT0000102) to Evaluate the Long-term Effect of Carvedilol versus Propranolol on Reduction in Portal Pressure in Patients with Cirrhosis(CARPE study) at end of treatment. Patients within 6 months after the end of CARPE study
(2)Poor compliance to propranolol in CARPE study. Patients within 6 months with after the end of CARPE study
(1) systolic blood pressure < 90 mmHg, baseline heart rate < 55/min
(2) refractory ascites, hepatic encephalopathy, hepatorenal syndrome
(3) hepatocellular carcinoma
(4) presence of severe systemic illness
(5) history of gastric variceal hemorrhage
(6) contraindication of beta-blocker
(7) serum jaundice > 10 mg/dL
(8) srum creatinine = 1.2 mg/dL
(9) history of shunt or TIPS
(10) IDDM
(11) pregnancy, lactation
(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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method reduction of hepatic pressure gradient
- Secondary Outcome Measures
Name Time Method compliance;incidence of variceal bleeding;evaluation of non-invasive test