Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594783
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Carvedilol Plus EVL or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Carvedilol Plus Endoscopic Ligation or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVL-NR
Brief Summary:
The goal of this clinical trial is to evaluate whether carvedilol plus endoscopic variceal ligation EVL is more effective for the primary prevention of esophageal variceal bleeding than carvedilol alone in carvedilol non-responders It will also learn about the safety of carvedilol combined with EVL in patients with cirrhosis
The main questions it aims to answer are
Whether carvedilol plus EVL is more effective than carvedilol alone in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol
What medical problems do participants have when taking carvedilol or taking carvedilol combined with undergoing EVL Researchers will compare the efficacy and safety of carvedilol with or without EVL in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol
Participants will
Take carvedilol every day start from 625 mgd and then titrate to 125 mgd if tolerable and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol or Take carvedilol alone every day start from 625 mgd and then titrate to 125 mgd if tolerable
Visit the clinic once every 2-3 months for checkups and tests Keep a diary of their vital signs SBP DBP and HR as well as symptoms
The main questions it aims to answer are
Whether carvedilol plus EVL is more effective than carvedilol alone in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol
What medical problems do participants have when taking carvedilol or taking carvedilol combined with undergoing EVL Researchers will compare the efficacy and safety of carvedilol with or without EVL in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol
Participants will
Take carvedilol every day start from 625 mgd and then titrate to 125 mgd if tolerable and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol or Take carvedilol alone every day start from 625 mgd and then titrate to 125 mgd if tolerable
Visit the clinic once every 2-3 months for checkups and tests Keep a diary of their vital signs SBP DBP and HR as well as symptoms
Detailed Description:
Gastro-esophageal variceal bleeding is a major complication of portal hypertension and carries a high rate of rebleeding and mortality How to prevent the first esophageal variceal bleeding EVB in patients with cirrhosis and portal hypertension has always been a very important issue According to the latest Baveno VII consensus on the treatment of portal hypertension published in December 2021 nonselective beta-blockers NSBB should be used first to prevent decompensation in patients with clinically significant portal hypertension Endoscopic variceal ligation EVL is recommended for compensated patients with high-risk esophageal varices EVs who have contraindications or an intolerance to NSBBs
Carvedilol is a kind of NSBB and has extra intrinsic anti-α1 adrenergic activity Carvedilol can reduce hepatic venous pressure gradient HVPG better than propranolol and is currently the drug of choice for the primary prevention of EVB in patients with cirrhosis and CSPH Although the HVPG-lowering effect of carvedilol is stronger than that of propranolol up to 38-46 patients with CSPH are still carvedilol non-responders Follow-up upper gastrointestinal endoscopy of these patients may show EVs become larger more numerous or have new red color signs which indicate the increasing risk of EVB However studies discussing treatment options for patients with cirrhosis and EVs who do not respond to carvedilol therapy are scarce
In this project the investigators will initiate an open-label randomized controlled trial aiming at comparing the efficacy of carvedilol plus EVL or not for the primary prevention of EVB in cirrhotic patients who are carvedilol non-responders The investigators will also explore if there is any difference between the two groups in terms of other upper gastrointestinal bleeding non-bleeding liver decompensation such as new onsetworsening ascites hepatic encephalopathy spontaneous bacterial peritonitis and hepatorenal syndrome overall survival adverse events tolerability and safety The investigators will also analyze whether there is a difference of the two groups in preventing the first EVB in patients with varying degrees of cirrhosis who are carvedilol non-responders
Carvedilol is a kind of NSBB and has extra intrinsic anti-α1 adrenergic activity Carvedilol can reduce hepatic venous pressure gradient HVPG better than propranolol and is currently the drug of choice for the primary prevention of EVB in patients with cirrhosis and CSPH Although the HVPG-lowering effect of carvedilol is stronger than that of propranolol up to 38-46 patients with CSPH are still carvedilol non-responders Follow-up upper gastrointestinal endoscopy of these patients may show EVs become larger more numerous or have new red color signs which indicate the increasing risk of EVB However studies discussing treatment options for patients with cirrhosis and EVs who do not respond to carvedilol therapy are scarce
In this project the investigators will initiate an open-label randomized controlled trial aiming at comparing the efficacy of carvedilol plus EVL or not for the primary prevention of EVB in cirrhotic patients who are carvedilol non-responders The investigators will also explore if there is any difference between the two groups in terms of other upper gastrointestinal bleeding non-bleeding liver decompensation such as new onsetworsening ascites hepatic encephalopathy spontaneous bacterial peritonitis and hepatorenal syndrome overall survival adverse events tolerability and safety The investigators will also analyze whether there is a difference of the two groups in preventing the first EVB in patients with varying degrees of cirrhosis who are carvedilol non-responders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None