Clinical Research Directory

Effects of Empagliflozin on Fibrosis and Cirrhosis in Chronic Hepatitis B Patients

Chronic hepatitis B (CHB) affects 257million individuals worldwide. In 2017, it caused around 39.7 million cases of cirrhosis and 0.4 million cirrhosis-related deaths in 2017. However, there is no specific treatment for liver fibrosis/cirrhosis. Although nucleos(t)ide analogues (NAs) profoundly suppress viral replication, fibrosis/cirrhosis progression can still occur in NA-treated patients. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors are antidiabetic drugs that may prevent fibrosis/cirrhosis progression by reducing hepatic steatosis/inflammation, dampening renin-angiotensin aldosterone system (RAAS) activation, and reducing fluid retention, effects of which are independent of glycemic control. Clinical studies in diabetic patients show SGLT2 inhibitors reduce hepatis steatosis/inflammation, regress ascites (a cirrhotic complication), and improve liver function parameters and survival prognosis in terms of model for end-stage liver disease (MELD) score. There are currently no randomized controlled trials (RCTs) on role of SGLT2 inhibitors in preventing fibrosis/cirrhosis progression in CHB patients. Magnetic resonance elastography (MRE) and transient elastography (TE) are non-invasive techniques for liver stiffness measurement (LSM), although MRE is more accurate than TE. The investigators propose a double-blind, randomized, placebo-controlled trial to compare effect of empagliflozin (an SGLT2 inhibitor) with placebo (1:1 ratio) in preventing fibrosis progression in both diabetic and non-diabetic NA-treated CHB patients with significant/advanced fibrosis or compensated cirrhosis. 108 patients will be randomly sampled from our pre-existing TE database. Empagliflozin 10mg daily will be given to treatment arm. Placebo pills will be manufactured identical in appearance to empagliflozin. Subjects will receive active or placebo pills for three years, and undergo clinical, anthropometric and laboratory assessments (at baseline, weeks 8, 16, and every 4 months thereafter). They will undergo LSM by TE at baseline, end of first, second and third year, and by MRE at baseline and end of third year. Primary outcome is difference in change to liver stiffness (measured by MRE) from baseline between the two groups at the end of third year. The study results will determine whether SGLT2 inhibitors can prevent hepatic fibrosis/cirrhosis progression in NA-treated CHB patients.

CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes in Non-diabetic ACS Patients Without HF

The goal of this clinical trial is to learn if dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), can reduce coronary artery inflammation in people with acute coronary syndrome (ACS) who do not have diabetes or heart failure. Coronary inflammation will be measured using the fat attenuation index (FAI), a marker derived from coronary CT angiography (CCTA) that quantifies inflammation in the fat tissue surrounding heart arteries. The main questions it aims to answer are: * Does dapagliflozin lower coronary artery inflammation as measured by FAI? * Does dapagliflozin slow the progression of coronary plaques? Researchers will compare participants who take dapagliflozin 10 mg daily plus standard therapy to those who receive standard therapy alone for 6 months. Participants will: * Undergo percutaneous coronary intervention (PCI) for ACS * Have a baseline CCTA scan at 1 month after PCI, at which point they will be randomly assigned to receive dapagliflozin or standard care alone * Have a follow-up CCTA scan at 6 months after randomization * Have blood tests at the time of PCI, at randomization, and at 6 months after randomization * Receive follow-up phone calls at 3 and 6 months after randomization

Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients

The main aim of this study is to holistically assess the cardiovascular and renal outcomes in HFpEF CKD patients with and without SGLT2 inhibition, with focus on the endothelial disfunction, MACE and mortality using clinical evaluation, flow mediated dilatation, carotid-femoral pulse wave velocity, intima-media thickness, echocardiographic parameters, NMR metabolomics and a series of novel biomarkers.

Efficacy of SGLT2 Inhibitors in Adults With Sepsis

Goal of this clinical trial is to examine the safety and efficacy of SGLT2 inhibitors on the clinical outcomes in patients with sepsis. Main study outcomes are as follows: (i) Primary objective is to examine the efficacy and safety of SGLT2 inhibitors on clinical outcomes in patients with sepsis. (ii) Secondary objective is to examine the effect of SGLT2 inhibitors on inflammatory markers in patients with sepsis.