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Cirrhosis clinical trials

View clinical trials related to Cirrhosis.

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NCT ID: NCT05028829 Recruiting - Cirrhosis Clinical Trials

Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk

TORCH
Start date: May 10, 2023
Phase: Phase 2
Study type: Interventional

Prospective randomized, multi-center, double blind placebo-controlled trial to assess the chemopreventive impact of atorvastatin (20 mg oral) vs placebo in up to 60 adults with advanced fibrosis at high risk of developing HCC.

NCT ID: NCT05027425 Recruiting - Clinical trials for Hepatocellular Carcinoma

Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant

Start date: December 7, 2021
Phase: Phase 2
Study type: Interventional

Immunotherapy can safely downstage patients and achieve durable systemic disease control to improve clinical outcomes in HCC patients undergoing liver transplant.

NCT ID: NCT05014594 Recruiting - Cirrhosis Clinical Trials

Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT

Start date: September 3, 2021
Phase: Phase 2
Study type: Interventional

The development of ascites is a landmark event in the natural history of cirrhosis and signifies a grim prognosis. Portal hypertension and splanchnic arterial vasodilatation are the major contributors in the development of ascites. Vasodilatation with the consequential decrease in effective circulating volume leads to the activation of sympathetic nervous system and renin angiotensin aldosterone system (RAAS), leading to antinatriuretic effects and retention of sodium and water. This results in the formation of ascites. Management of ascites primarily consists of salt restrictrion and diuretics. Liver transplant is the ultimate panacea. Dapaglifozin, a Sodium glucose linked transporter-2(SGLT-2) inhibitor, is a part of the routine armamentarium for treatment of patients with Diabetes Mellitus type-2. Its safety is well established in non-diabetic patients too where it has been shown to improve cardiovascular outcomes. The risk of hypoglycemia is negligible as its action is independent of insulin. By virtue of its natriuretic effect, it has been shown to reduce hospitalisations in patients with heart failure irrespective of the presence of diabetes. We hypothesise that a similar natriuretic effect may help in suppressing the renin-angiotensin axis with improved mobilization of ascites in patients with cirrhosis. Pharmacokinetic data on the use of Dapaglifozin suggest that there is no need for dose modification in cirrhosis. The AUC and Cmax for Dapaglifozin in Child Pugh C cirrhosis is 67% and 40%, respectively. In a recent small case series, SGLT-2 inhibitors including dapaglifozin led to improvement in fluid retention and serum sodium, without acute kidney injury or encephalopathy, in patients with cirrhosis. However, SGLT-2 inhibitors have not been evaluated in randomized controlled trials. In this pilot study, we plan to evaluate the efficacy and safety of dapaglifozin in cirrhotics patients with recurrent ascites.

NCT ID: NCT04915573 Recruiting - Cirrhosis Clinical Trials

Antimicrobial Resistance in Cirrhotic Patients

Start date: June 7, 2021
Phase:
Study type: Observational

Cirrhotic patients are more vulnerable to bacterial infection, and infection is one of the most common causes of acute liver disease decompensation.

NCT ID: NCT04836923 Recruiting - Frailty Clinical Trials

LIFT Intervention in Liver Transplant Candidates

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible. In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins. The investigators also aim to perform "Realistic Effort Action Planning" (REAP), which is a form of personality-informed motivational interviewing, in a subset of patients to determine if this enhances the LIFT intervention.

NCT ID: NCT04807803 Recruiting - Cirrhosis Clinical Trials

Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension

Evencipor
Start date: March 26, 2021
Phase: N/A
Study type: Interventional

Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.

NCT ID: NCT04807023 Recruiting - Cirrhosis Clinical Trials

Decompensation of Cirrhosis and Iron Metabolism

DeCiFer
Start date: May 17, 2021
Phase:
Study type: Observational

Iron is a crucial metal whose metabolism is tightly regulated. Iron deficiency or iron overload are both deleterious at the cellular, organic and systemic levels. In line with the major role of the liver in iron homeostasis, links between iron metabolism and acute on chronic liver failure have been highlighted. Nevertheless, due to the difficulty of accurately assessing iron metabolism in this situation, therapeutic intervention on iron metabolism in this setting is currently not codified. A better understanding of these mechanisms is therefore essential, in particular by characterizing the impact of exposure to non-transferrin-bound iron in acute on chronic liver failure on short-term mortality. Overall, a better understanding of the physiopathological mechanisms of iron should allow to optimize the martial balance in this condition and also improve therapeutic approaches.

NCT ID: NCT04786743 Recruiting - Cirrhosis Clinical Trials

Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT

TEACH
Start date: April 20, 2021
Phase: N/A
Study type: Interventional

Acute variceal upper gastrointestinal hemorrhage remains a hot potato in cirrhotic patients. The purpose of this study is to figure out whether urgent endoscopy (within 6h after gastroenterological consultation) is superior to non-urgent endoscopy (between 6h and 24h after gastroenterological consultation) in reducing re-bleeding for these patients. This is a single-centered, prospective, randomized, and controlled trial. 400 patients with suspected variceal bleeding will be randomized in a 1:1 ratio to receive endoscopic intervention either within 6h or 6-24h. Randomization is conducted by permuted block randomization stratified by age, systolic blood pressure (SBP), and pulse rate. The primary efficacy endpoint is rebleeding within 42 days after control of acute variceal bleeding. This trial will provide valuable insights into the efficacy between the urgent endoscopy group and the non-urgent endoscopy group.

NCT ID: NCT04633356 Recruiting - Cirrhosis Clinical Trials

EUS Guided Portal-systemic Pressure Gradient Measurement

Start date: November 12, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Portal hypertension is characterised by an increased portal pressure gradient (PPG), that is the difference in pressure between the portal vein and the inferior vena cava (IVC). Portal hypertension is a consequence of cirrhosis resulting from chronic hepatitis. Patients with portal hypertension are at risk of developing complications including oesophageal or gastric varices, variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy and mortality. Albeit its clinical significance, direct measurement of portal venous pressure to document portal hypertension has traditionally been difficult. The portal vein pressure can be measured by transhepatic or transvenous methods but the procedure carries a risk of intra-peritoneal bleeding. Furthermore, the IVC pressure measurement requires further transjugular catheterisation. Hence, the technique is rarely used. Currently, the gold standard in measurement of portal hypertension is via measurement hepatic venous pressure gradient (HVPG). The HVPG has been shown to correlate with risk of clinical decompensation, development of varices, hepatocellular carcinoma, variceal bleeding, spontaneous bacterial peritonitis and mortality. Nevertheless, the technique has a low acceptance rate amongst patients and it may not be available even in tertiary medical centres. Recently, the use of EUS-guided approach for measurement of portal pressure gradient (PPGM) has been shown to be feasible. The technical success rate was 100% and no adverse events were reported. Measurements obtained with the EUS approach was shown to correlate excellently with clinical parameters of portal hypertension including presence of varices, portal hypertensive gastropathy and thrombocytopenia. Furthermore, the procedure could be performed at the same time of screening oesophagogastroduodenoscopy (OGD), that is frequently required for variceal screening in this group of patients. Hence, the aim of the current study is to investigate the feasibility of EUS-PPGM and correlate the risk of developing complications with the PPGM in patients that are suffering from chronic hepatitis.

NCT ID: NCT04620538 Recruiting - Clinical trials for Hepatocellular Carcinoma

Volatile Organic Compounds for the Assessment of Liver Disease

VOCAL
Start date: April 1, 2021
Phase:
Study type: Observational

This study aims to determine whether a breath test could be used for early detection of hepatic fibrosis, cirrhosis or hepatocellular carcinoma. Patients who are attending for a planned liver outpatient services or investigations will be approached to provide a breath sample. Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between fibrosis, cirrhosis and hepatocellular carcinoma.