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Portal Hypertension clinical trials

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NCT ID: NCT06122753 Not yet recruiting - Portal Hypertension Clinical Trials

Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis

Start date: January 2024
Phase: N/A
Study type: Interventional

Portal vein thrombosis (PVT) can lead to a further increase in portal venous pressure and increase the risk of rebleeding. Whether patients with acute esophagogastric variceal bleeding with occlusive PVT benefit from preemptive TIPS is still controversial. The present study is directed at comparing the outcome of patients with acute variceal bleeding with occlusive PVT treated by standard therapy (vasoactive drugs + endoscopic variceal ligation) with or without preemptive TIPS (performed during the first 1-3 days after endoscopic procedure). The primary outcome is survival free of variceal rebleeding at 6 weeks from inclusion.

NCT ID: NCT06117735 Recruiting - Portal Hypertension Clinical Trials

Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

Start date: November 30, 2023
Phase: N/A
Study type: Interventional

To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.

NCT ID: NCT06099015 Not yet recruiting - Portal Hypertension Clinical Trials

Cera™ Vascular Plug System Post-Market Clinical Follow-Up

Start date: June 2024
Phase:
Study type: Observational

The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: - confirm the performance - confirm the safety - identify previously unknown side-effects - monitor the identified side-effects (related to the procedures or to the medical devices) - identify and analyse emergent risks

NCT ID: NCT06097715 Not yet recruiting - Portal Hypertension Clinical Trials

Clinical,Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases

Start date: November 2023
Phase: N/A
Study type: Interventional

Portal hypertension is a significant cause of morbidity and mortality in children with chronic liver disease and portal vein obstruction. It results in severe complications such as ascites, hepatic encephalopathy and gastrointestinal variceal bleeding. (Sutton et. al., 2018). Esophageal varices is an important manifestation of portal hypertension that develops over time in children with chronic liver disease. The risk of esophageal varices hemorrhage increases depending on the underlying disease as well as the duration of the disease and the mortality rate as high as 5% - 20 % during patient follow up. Invasive procedures such as gastroscopy are performed repeatedly to detect the presence and progression of esophageal varices. Many non-invasive methods have been investigated to their efficacy in determining the presence of esophageal varices and the risk of complications in the presence of portal hypertension. (Taşkın et.al., 2023). Early diagnosis of portal hypertension is often difficult as it can be asymptomatic. During this stage, the patient may feel nothing except for mild fatigue or abdominal discomfort and therefore, patients mostly go undiagnosed (Hartl et.al., 2021). (Selicean et.al., 2021). However, it is worth noting that some of the results from medical investigation may be abnormal during this stage. These include abnormal liver function, abnormal routine blood examination (thrombocytopenia), and changes in the stiffness of the liver which can be found during ultrasound despite the patient being asymptomatic. ( Mohanty et al., 2021). Though the gold standard to diagnose portal hypertension is hepatic venous pressure gradient (HVPG) and a value more than 10 mmHg defines clinically significant portal hypertension (CSPH) ( Man Zhang et.al., 2022). Since HVPG measurement is scarcely available and invasive, several non-invasive tests are used as surrogate markers of CSPH. Amongst them, elastography techniques measuring liver stiffness (LS) and spleen stiffness (SS) are the extensively studied ones which can be done by elastography machines that can be attached to conventional ultrasound (USG) machines . Amongst them, 2D-shear wave elastography (2D-SWE) is the most recent one, and it assesses stiffness and related parameters by tracking shear waves propagated through a media. (Sattanathan et.al., 2023).

NCT ID: NCT06054451 Recruiting - Portal Hypertension Clinical Trials

Clinical Diagnosis and Pathological Spectrum of Porto-sinusoidal Vascular Disease in India

PSVD-India
Start date: August 1, 2023
Phase:
Study type: Observational

There is a need to re-evaluate the patients classified as NCPH and determine whether the new histological classification proposed by the VALDIG applies to the Indian scenario. We intend to identify the patient cohorts who have been diagnosed as NCPH, NCPF, EHPVO, hepatic venous outlet tract obstruction (HVOTO), Veno-occlusive disease (VOD) and sinusoidal obstruction syndrome (SOS) based on their liver biopsy, endoscopy, HVPG, and radiology reports. These patients will be screened to find the patients who fit the diagnosis of PSVD. It is important to establish whether the new definition of PSVD is relevant to the Indian population and establish the usefulness of invasive tests like liver biopsy in diagnosing the disease. The patient cohorts meeting diagnosis of INCPH will be compared with those meeting the new diagnosis of PSVD. The investigators will describe the clinical (demographic, clinical risk factors, socioeconomic status), etiological (associated conditions, coagulation disorders medication use, genetic risk factors), imaging (based on ultrasound Doppler imaging or cross- sectional imaging), endoscopic, fibrosis tests (using non-invasive tests), and the histopathology of the patients who fulfil the criteria of PSVD.

NCT ID: NCT06013670 Recruiting - Portal Hypertension Clinical Trials

Standard Therapy and TIPS for Moderate to High-risk Esophageal and Gastric Variceal Bleeding

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Comparison of endoscopic therapy combined with non-selective therapy β Receptor blockers (NSBBs) and TIPS in the treatment of liver cirrhosis The impact of reducing bleeding on the survival of critically ill patients. To compare the effect of endoscopic therapy combined with NSBBs drugs and TIPS on rebleeding and incidence of Hepatic encephalopathy in patients with moderate risk of liver cirrhosis hemorrhage.

NCT ID: NCT06000748 Recruiting - Acute Kidney Injury Clinical Trials

NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients

NEPH-ROSIS
Start date: February 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that has low (<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be: 1) Randomized to a clinical algorithm that will either target a low (<80 mmHg) or high (≥80 mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications to a specific MAP target. Researchers will compare the high and low MAP-target groups to see if these algorithms lead to significant changes in MAP, if they have any impact on AKI reversal, and if there are any adverse events in the high MAP-target group.

NCT ID: NCT05928624 Recruiting - Portal Hypertension Clinical Trials

A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients

WATCH
Start date: September 22, 2023
Phase: N/A
Study type: Interventional

This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.

NCT ID: NCT05872698 Recruiting - Portal Hypertension Clinical Trials

Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.

BOPPP
Start date: June 1, 2019
Phase: Phase 4
Study type: Interventional

Research has proven that large varices can be treated with beta-blockers (a type of anti-hypertensive medication) to reduce the pressure in the veins. The management of small varices is still uncertain. This study aims to discover if beta blockers can be used in this setting. We hypothesize that beta blockers will reduce the risk of bleeding from small varices from 20% to 10% over a period of 3 years, resulting in significant cost savings to the NHS from better patient outcomes.

NCT ID: NCT05794555 Recruiting - Portal Hypertension Clinical Trials

LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

Start date: June 13, 2023
Phase: Phase 3
Study type: Interventional

This multicenter trial is being conducted to determine if sequential lactulose and Tele (virtual) Tai-Chi reduces the rate of injurious fall, non-injurious falls, incident overt Hepatic Encephalopathy (HE), and death or liver transplant over 24 weeks. Participants that are enrolled will be randomized to stage one of this project for approximately 12 weeks. After completing stage one, participants will be re-randomized to stage 2 of the project that will last approximately 12 more weeks. The study hypothesizes that sequential lactulose/TeleTai-Chi will reduce falls, incident overt HE, death and physical frailty and will improve cognitive function, and Health Related Quality of Life (HRQOL) over 24 weeks compared to other treatment combinations.