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Portal Hypertension clinical trials

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NCT ID: NCT03438916 Completed - Liver Cirrhosis Clinical Trials

MRI to Assess the Effect of Non-selective Beta-blocker in Patients With Cirrhosis

Start date: April 1, 2017
Phase:
Study type: Observational

Background: Standardization and new therapeutic treatments of variceal bleeding has significantly reduced the mortality the last 25 years, but there is still a high 6-week mortality around 15-20% and 1-year mortality of about 40%. Cirrhotic patients without prophylactic treatment suffer a risk of 60% of re-bleeding within the first year after the first bleeding episode. Variceal ligation and NSBB are the standard therapy as secondary prophylaxis, while only non-selective beta-blocker (NSBB) is offered as first-line therapy in primary prophylaxis. If portal pressure is reduced to a value below 12 mmHg or by 20% (10% if assessed by intravenous administrations), the risk of bleeding is substantially reduced, but not all patients respond to the treatment with propranolol (40-50%). Hence, patients who are non-responders to NSBB should be offered alternative treatment with e.g. carvedilol, which is a combined alpha-beta-receptor blocker or endoscopic band ligation. Currently, the response to NSBB is assessed invasively during a liver vein catheterization (LVC). Unfortunately, only a few centres in the world can perform this procedure and there are no reliable non-invasive alternatives to assess the respond to NSBB, which is of extreme importance, since non-responders have three fold increased risk of a new variceal bleeding episode. Aim: In general the aim of the project is to develop faster and non-invasive methods to evaluate portal hypertension and individual pharmacological response of NSBB in patients with cirrhosis. Furthermore, we expect to detect changes in liver and spleen stiffness as measured by MR-Elastography (MRE) after NSBB and that these depend on the drug-related effects on portal pressure. Study design and patients: 39 patients with cirrhosis and esophageal varices that require NSBB (propranolol) treatment. Patients are assessed with LVC, MR-scans, echocardiography and biochemical tests. LVC is the gold standard method to test if patients respond to propranolol treatment. At visit 1. the response to NSBB is defined as a reduction of HVPG ≥10%, or to a HVPG< 12mmHg after intravenous NSBB administrations during LVC. MRI-scan with intraveneus NSBB administration is performed at visit 2. Minimum 5 days of NSBB wash out between visit 1 and 2.

NCT ID: NCT03436550 Completed - Portal Hypertension Clinical Trials

Assessment of Portal Hypertension With Multiparametric MRI

Start date: March 20, 2018
Phase:
Study type: Observational

The purpose of this study is to determine whether new multiparametric magnetic resonance imaging (MRI) methods (including diffusion-weighted MRI, dynamic contrast-enhanced MRI, MR elastography and phase-contrast imaging) can be useful in assessing liver damage and degree of portal hypertension (a complication of advanced liver fibrosis and cirrhosis) secondary to chronic liver disease, compared to ultrasound measurement of liver stiffness [acoustic radiation force impulse (ARFI) ultrasound] and routine blood tests. MRI uses magnetic fields to look at soft tissues in the body. This study will ultimately help to determine whether these methods will be useful in identifying liver disease and their complications that cannot be well-understood using current liver MRI techniques.

NCT ID: NCT03427164 Completed - Portal Hypertension Clinical Trials

Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure

Start date: October 16, 2017
Phase: N/A
Study type: Interventional

The primary purpose of this project is to determine if acute monitoring of shunt patency via ultrasound elastography measurements of splenic stiffness before and after TIPS placement results in reduced morbidity and mortality from shunt failure.

NCT ID: NCT03155282 Completed - Portal Hypertension Clinical Trials

Utility of EUS-elastography to Predict Portal Hypertension

Start date: March 1, 2017
Phase:
Study type: Observational

Patients with cirrhosis have structural and functional alterations of the liver. The progressive deposition of hepatic fibrosis is related to the subsequent development of portal hypertension (PH), and PH is associated with mayor complications including ascites, hepatic encephalopathy and development of gastroesophageal varices with a high risk of bleeding. Variceal bleeding is a medical emergency associated with a 6-week mortality rate of approximately 10-20%. Liver biopsy is the gold standard for the assessment of hepatic fibrosis, whereas the measurement of hepatic vein pressure gradient (HVPG) is the standard to evaluate PH and upper endoscopy (UE) is the method of choice to detect the presence and grade of gastroesophageal varices. The last two also estimates the risk of variceal bleeding. Unfortunately, clinical investigation of PH implies HVPG measurement or endoscopy for esophageal varices (EV) screening and grading. The first one is an invasive technique, mainly restricted to tertiary centers, that requires personal training, increased health care costs and patient discomfort. The UE, even though has demonstrated utility to predict HVPG (HVPG value ≥ 10 mmHg predicts the presence of EV and a value ≥ 12 mmHg is predictive for variceal bleeding), has been criticized of being subjective. Because of this, alternative test including elastographic techniques, have been develop to assess the severity of PH, the presence of EVs and the risk of variceal bleeding. Elastography is a technique used to measure tissue elasticity and stiffness in real time, by the application of slight compression using a transducer to the targeted tissue. The principle is that tissue compression produces deformation (strain) and that the strain is smaller in harder tissue as compared to softer tissue. Consequently, by measuring the tissue strain induced by compression, it is possible to estimate the tissue hardness. Fibroscan® (FS) (Echosens, París, Francia) uses the principle of one-dimension transient elastography (TE) for the assessment of tissue stiffness. It was used initially for liver stiffness measurement (LSM) and proved to be reliable for the diagnosis of liver cirrhosis and avoid liver biopsy in 90% of cases. Also LSM by TE accurately correlates with the severity of PH and the presence of esophageal varices.

NCT ID: NCT03083925 Completed - Portal Hypertension Clinical Trials

Viatorr CX Case-control Study for Complications of Portal Hypertension

VIATORR-CX
Start date: May 23, 2016
Phase:
Study type: Observational

To evaluate the clinical benefits in the patients receiving Viatorr CX over a period of 12 months of structured Follow-up (before TIPS, at TIPS, 1 week after TIPS, at 6 weeks, 4 months, 6 months, 9 months, 12 months), regarding clinical endpoints, such as HE, readmission, liver injury, cardiac function, response to TIPS and the passive expansion of the stents in real life.

NCT ID: NCT03072615 Completed - Portal Hypertension Clinical Trials

Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS

TIPS-SWE
Start date: April 1, 2013
Phase: N/A
Study type: Observational

The aim of our prospective multicenter study was to investigate the prognostic value of the acute and long-term changes of liver stiffness in patients receiving a transjugular intrahepatic portosystemic shunt (TIPS).

NCT ID: NCT03031366 Completed - Portal Hypertension Clinical Trials

A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap

Start date: February 13, 2017
Phase: N/A
Study type: Interventional

TIPS creation has been widely used to treat the complications associated with portal hypertension. In association with increased operator experience and the ongoing development of imaging modalities, the rate of major complications associated with TIPS has decreased significantly in the past decades. However, the passage of a curved needle from the hepatic vein into the portal vein still remains a challenging and time-consuming part of the procedure and is associated with puncture-related complications that are potentially fatal.Three-dimensional roadmap guidance has been widely applied in various interventions. The aim of the present study is to prospectively assess the feasibility and efficacy of real-time 3D roadmap guidance during TIPS creation.

NCT ID: NCT02994485 Completed - Portal Hypertension Clinical Trials

Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin

Start date: October 2016
Phase: Phase 4
Study type: Interventional

Portal hypertension is not a disease in itself. Rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by more than 5 mm Hg.

NCT ID: NCT02960204 Completed - Cirrhosis Clinical Trials

Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension

ENCORE-PH
Start date: October 17, 2016
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.

NCT ID: NCT02907749 Completed - Cirrhosis Clinical Trials

Spironolactone on Fibrosis Progrssion-Portal Hypertension(FP-PH)in Cirrhosis

FP-PH
Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate the effects of spironolactone on liver fibrosis progression and portal pressure gradient in patients with advanced chronic liver disease. Eligible cirrhosis patients were 2:1 randomized to either combination (carvedilol and spironolactone) or single (carvedilol) therapy group. Changes in virtual portal pressure gradient (vPPG) of portal trunk (calculated based on reconstructed 3D model and measured blood flow velocity), liver stiffness measurement (Fibroscan) and serum markers of liver fibrogenesis were documented at baseline and six months later.