| NCT ID | NCT07281846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | BCAA |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2027-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2025-11-15 with a primary completion date of 2027-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cirrhosis is a major global cause of morbidity and mortality in chronic liver disease patients, accounting for 2.4% of global deaths in 2019. A 1990-2017 Global Burden of Disease study showed rising cirrhosis-related deaths, bringing heavy health and economic burdens. It often leads to portal hypertension and subsequent complications like ascites, gastroesophageal variceal bleeding (20% 6-week mortality), and hepatic encephalopathy (HE). Transjugular intrahepatic portosystemic shunt (TIPS) is an important treatment for variceal bleeding and refractory ascites per guidelines from EASL, AASLD, and the Chinese Medical Association. Malnutrition affects 20% of compensated and over 50% of decompensated cirrhotic patients; sarcopenia (severe malnutrition) is linked to higher cirrhosis-related complications, impaired quality of life, survival, and poor prognosis in TIPS-treated patients. Thus, concurrent sarcopenia intervention during TIPS may improve outcomes. Baveno VII, EASL, and AASLD guidelines recommend branched-chain amino acid (BCAA) and leucine-rich supplements for decompensated cirrhosis to ensure adequate nitrogen intake. RCT evidence shows BCAAs improve skeletal muscle index (SMI) in cirrhotic patients with sarcopenia and reduce HE risk, but evidence for TIPS-treated patients is lacking. This study aims to compare muscle mass changes and clinical prognosis between TIPS patients with sarcopenia, portal hypertension, and variceal bleeding who receive TIPS with or without BCAA supplements.
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 80 years old; 2. Diagnosed with cirrhosis complicated by sarcopenia; 3. Patients admitted due to variceal bleeding or refractory ascites who meet the indications for transjugular intrahepatic portosystemic shunt (TIPS). Exclusion Criteria: 1. Hepatocellular carcinoma and/or other malignant tumors; 2. Severe cardiopulmonary insufficiency; 3. Child-Pugh score \> 13 points; 4. Spontaneous recurrent hepatic encephalopathy (HE); 5. Large spontaneous portosystemic shunt; 6. Sepsis; spontaneous bacterial peritonitis (SBP); 7. Allergy to any component of the study nutritional supplement; 8. High-energy and high-protein diet or use of calcium supplements, vitamin D supplements, or protein/amino acid supplements within 3 months prior to the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07281846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying BCAA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07281846 currently recruiting?
Yes, NCT07281846 is actively recruiting participants. Contact the research team at baiyaowei918@163.com for enrollment information.
Where is the NCT07281846 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07281846 clinical trial?
NCT07281846 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 164 participants.