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165 active trials for Chronic Kidney Diseases

Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure

ITISHOPE4HF is a randomized controlled trial of telerehabilitation in a heart failure population. The goal is to evaluate if a home-based telerehabilitation project can increase physical activity in heart failure patients. Patient will be provided telerehabiliation or advice on physical activity (standard care).

Start: June 2017

Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis

The purpose of the study is to assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to the reference standard YSI (Yellow Spring Instruments) glucose in people with diabetes undergoing haemodialysis. The Dexcom G6 is a continuous glucose monitoring system that gives blood glucose values in real-time and includes alarms if the glucose is very low or high. The Abbott FreeStyle ibre flash system is an intermittent glucose monitor that shows the blood glucose values when it is waved near the sensor and does not include alarms. The YSI glucose analysis will take place as a normal part of haemodialysis, by testing blood glucose levels during the haemodialysis session. The study will last 28 days per participant

Start: December 2019

Resveratrol and Vascular Function in CKD

The proposed research is clinical study evaluating the therapeutic benefits of resveratrol on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that resveratrol will improve endothelial function and functional performance by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress.

Start: January 2019

Assessing Bone Calcium Content in Children With Kidney Disease Treated With Two Different Medicines

This is an open label, time series trial. The trial is likely to be single centre (additional sites will only be opened if necessary) and will involve 25 children with chronic kidney disease (stage 3b, 4-5) or on dialysis. The overall aim of this trial is to explore the viability of the Ca isotope ratio measured by dual-tracer stable Ca isotope method as a measure of bone mineral (Ca) content, and to evaluate how it changes in response to two commonly used medications that either contain Ca (calcium carbonate) or do not (sevelamer carbonate). Both calcium carbonate and sevelamer carbonate are routinely used in children, but their effect on the bone mineral content (measured by the Ca isotope ratio) has not been studied. This short-term trial will provide proof-of-concept data to determine the utility of the Ca isotope fractionation technique in guiding medication usage in children with CKD and on dialysis. These data will inform a potential future randomised trial that utilises the calcium isotope fractionation technique to adjust the calcium intake (through diet and different medications, including vitamin D analogues) and monitor changes in important patient level outcomes such as fractures and bone mineral density on DXA scan. Participants will be administered sevelamer carbonate first for 16 weeks and then will switch to calcium carbonate for 12 weeks. Participants may need to change medication earlier than 16 weeks at the clinician's discretion based on their calcium levels on routine blood tests. Calcium isotope levels will be measured in blood and urine samples for up to 28 weeks. Isotopes levels in faeces and dialysis fluid samples may also be measured. This is not a Clinical Trial of an Investigational Medicinal Product (CTIMP).

Start: January 2020

Curcumin and Exercise in Chronic Kidney Disease

Chronic kidney disease (CKD) is associated with a pro-oxidative and pro-inflammatory state, and this is thought to contribute to a decrease in vascular function leading to greater cardiovascular disease (CVD) risk. Curcumin supplementation has been shown to reduce oxidative stress and improve endothelial function at rest in healthy older humans, although the magnitude of this effect remains unknown during exercise in CKD. The primary aim of this proposal is to determine whether exercising blood flow and vasoconstrictor responsiveness are improved as a result of acute oral supplementation with curcumin in patients with CKD. We hypothesize that: 1) acute curcumin supplementation will increase steady state exercise blood flow, and 2) reduce vasoconstriction induced by an acute sympathetic stimulus (cold pressor test) CKD.

Start: November 2020

Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions

The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions.

Start: October 2019

Kidney Recovery After Acute Kidney Injury - Longitudinal Study

The endothelin (ET) system is an active target in human Acute Kidney Injury (AKI). Our primary hypothesis is that the circulating blood concentration of ET will be higher in patients with AKI than in matched controls.

Start: January 2020

MySlainte: Testing the Effect of Involving Partners in a CVD Prevention Community Lifestyle Program

MySláinte is a 12-week community-based, multi-disciplinary preventive and lifestyle intervention program to reduce CVD risk factors. It includes weekly exercise classes with educational workshops on understanding lifestyle risk factors as well as optimisation of cardiovascular medications. It will be delivered by a multidisciplinary team including: a nurse, dietician, physiotherapist and physician and builds on the previously developed protocols of the successful MyAction program. The MySlainte study aims to expand on the MyAction program by looking at a broader range of patients with chronic disease who have suboptimal lifestyle drivers for many preventable diseases. Importantly, MySlainte also aims to assess if there is a difference in outcome between those who complete the program with their partner compared to those who complete the program alone.

Start: March 2020

Effect of Acute Fructose Load in Human

The metabolism of the monosaccharide fructose is less controlled than the metabolism of glucose, which will result in the metabolic product uric acid. Elevated serum uric acid levels are associated with increased risk, or worsening, of chronic kidney disease. The mechanisms by which uric acid have detrimental effects are not well defined, but may include an increase in reactive oxygen species and subsequent inflammatory activity. The aim of this study is to investigate the effects of uric acid, markers of oxidative stress and markers of inflammation following a low fructose load reflecting normal conditions. This is an interventional study. On six different occasions patients with chronic kidney disease, patients with type 2 diabetes and healthy controls will receive Blueberry drink, Coca-Cola or pure Fructose drink with similar amount of carbohydrates (140 kcal) with and without a high fat meal represented by a pizza (425 kcal).Serum samples and urinary samples will be collected.

Start: February 2012

NAFLD Among Patients With Type 2 Diabetes and CKD

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in developed countries affecting approximately 30 % of the general adult population. It represents an important pathogenic factor in the development of type 2-diabetes and is associated with a high risk of cardiovascular disease. Previous studies of patients with chronic kidney disease (CKD) have demonstrated an increased risk for NAFLD and the presence of both CKD and NAFLD is likely to increase the risk for cardiovascular disease. The present protocol describes a study of the prevalence and etiology of NAFLD among patients with type 2-diabetes with CKD. The study is a cross-sectional study. Fat accumulation in the liver will be determined by Magnetic resonance (MR) spectroscopy and the prevalence of NAFLD among patients with type 2-diabetes with normal kidney function or CKD stage 3-5 will be investigated. A continuous glucose monitoring (CGM) for four days, Dual Energy X-ray Absorptiometry (DEXA) scanning, fibro scanning of the liver, bile acid analysis, metabolomic and lipidomic analysis will also be performed.

Start: May 2019

NAFLD Among Patients With Chronic Kidney Disease and the Effect of Kidney Transplantation

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in developed countries affecting approximately 30 % of the general adult population. It represents an important pathogenic factor in the development of type 2-diabetes and is associated with a high risk of cardiovascular disease. Previous studies of patients with chronic kidney disease (CKD) have demonstrated an increased risk for NAFLD and the presence of both CKD and NAFLD is likely to increase the risk for cardiovascular disease. The present protocol describes a study of the prevalence and etiology of NAFLD among patients scheduled for kidney transplantation and the possible effect of kidney transplantation on NAFLD. The project is a prospective cohort study. The effect of kidney transplantation in patients with prediabetes or normal glucose tolerance compared to healthy controls will be examined regarding development and progression of fat accumulation in the liver. Fat accumulation in the liver will be determined by magnetic resonance (MR) spectroscopy and the prevalence of NAFLD in the two groups will be investigated. A continuous glucose monitoring (CGM) for four days, Dual Energy X-ray Absorptiometry (DEXA) scanning, fibro scanning of the liver, bile acid analysis, metabolomic and lipidomic analysis will also be performed. An oral glucose tolerance test (OGTT) and an intra venous glucose infusion (IIGI) will be performed.

Start: May 2019

Epidemiology and Long-term Outcome of Patients With VHD

Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.

Start: January 2006

Atrial Fibrillation and Non-obstructive Coronary Lesions

Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with excessive risk of ischemic stroke and heart failure as well as reduced life expectancy. On the other hand, chronic coronary syndromes (CCS) remains the main cause of morbidity and mortality in an aging population. Both disease entities share common risk factors such as hypertension, diabetes and obesity The purpose of the study is to investigate the hypothesis indicating lack of significant coronary lesions in AF vs. sinus rhythm (SR) patients.

Start: January 2010

Sex Differences in Chronic Kidney Disease

This study aims to describe sex specific differences of the hemodialysis population in Austria, to quantify sex specific differences in treatment and outcomes in hospitalized patients with chronic kidney disease and to examine decision making by doctors and patients with regards to hemodialysis initiation. To adequately serve the needs of these research questions, the study is divided into 3 parts (sub-studies). Description and analysis of sex-specific differences in renal replacement therapy in Austria. Description and analysis of the competing risks of death versus renal replacement therapy initiation in the chronic kidney disease population by sex. Analysis of sex differences in renal replacement therapy initiation decisions, emphasizing patient perception and socio-economic differences.

Start: December 2018

Mindfulness in Chronic Kidney Disease

This study will test whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-inhibitory effects of mindfulness meditation (MM) and restores autonomic balance in CKD patients.

Start: September 2019

Volume 3D_US Kidney

The purpose of this study is to measure the volume of the kidney and tumors using 3D-US acquisition and to correlate these measurements to contrast-enhanced CT or MRI.

Start: June 2020

Enhanced Dynamic Clinical Decision Support System Pragmatic Trial (E-DYNAMIC)

Chronic kidney disease (CKD) is a highly prevalent, poorly recognized and undertreated and increases risk of atherosclerotic cardiovascular disease (ASCVD) and mortality. ASCVD risk interventions such as statin medications are not effective if initiated when kidney disease is advanced. Thus, early recognition of CKD is important for effective ASCVD risk management. Patient centered medical homes (PCMH)s (clinics which include nurse educators, dietitians, pharmacists and social workers) were designed to address gaps in care for complex chronic diseases such as CKD by increasing availability of ancillary services for patients. However, PCMH models have not been shown to improve the recognition and treatment of CKD and its associated ASCVD risk. The E DYNAMIC CDS retrieves real-time patient data from the electronic health record (EHR) every 24 hours to help primary care providers (PCP) identify patients with CKD and assess ASCVD risk and provide appropriate treatment. E-DYNAMIC also delegates CKD care with utilization of an opt-out approach for nurse education and dietitian referral. The overall objective of this pragmatic trial is to examine whether the E-DYNAMIC CDS increases PCP recognition of CKD and use of ASCVD risk management interventions when implemented within a PCMH. This pragmatic trial will be conducted within the Hines VA Hospital and community-based outpatient clinics designed as PCMH called teamlets. Teamlets include several PCPs, a nurse educator, a dietitian, a pharmacist, and a social worker. We will randomize 51 teamlets to the E-DYNAMIC CDS or to standard care. This pragmatic trial will address the following aims: 1) Determine the difference in PCP diagnosis of CKD stage 3-5 non-dialysis dependent CKD by allocation to the E-DYNAMIC CDS; 2) Determine the difference in PCPs ASCVD risk management of patients with stage 3-5 non-dialysis dependent CKD by teamlet allocation to the E-DYNAMIC CDS; 3) Determine the difference in patient use of ASCVD risk interventions and patient activation measures by their teamlet allocation to the E-DYNAMIC CDS. The primary outcomes of the pragmatic trial will be ascertained from the EHR. The E-DYNAMIC CDS tool may be transferred into other health systems that utilize an EHR and improve the diagnosis and management of CKD.

Start: January 2021

Diurnal BP Patterns in Those at Increased Risk of CVD

In health, blood pressure (BP) falls at night by >10% compared with day-time values. This natural dipping pattern is important as without it there is an increased risk of cardiovascular disease (CVD). Recent evidence suggests that chronotherapy (taking anti-hypertensive medication at bedtime instead of in the morning) may enhance nocturnal BP dipping and reduce the risk of CVD events. There is therefore an urgent need to characterise diurnal BP patterns in patients who may be at risk of reduced nocturnal dipping in order to maximise protective therapy in all those who would benefit. Similarly, it has previously been demonstrated that increased arterial stiffness is associated with increased CVD risk, however little is known about whether loss of diurnal variations in arterial stiffness confer addition risk. Kidney disease is independently associated with increased CVD events, but the exact makeup of this risk is not clear. Within this heterogenous cohort several very distinct groups exist including those with acute kidney injury (AKI), chronic kidney disease (CKD), inflammatory conditions like small vessel vasculitis (SVV), and those who have either donated or received a kidney transplant. Diurnal BP and arterial stiffness patterns within these patient groups are not well characterised. The investigators will recruit patients at increased risk of CVD from the Royal Infirmary of Edinburgh Renal and Vasculitis Clinics. Participants will undergo 24-hour ambulatory BP and arterial stiffness measurement in conjunction with day- and night-time blood and urine sampling on two separate occasions. This study aims to characterise diurnal patterns of BP and arterial stiffness in patients at increased risk of CVD and compare findings with healthy controls. In doing so, the investigators aim to allow more targeted CVD risk reduction strategies and improve long-term patient outcomes.

Start: March 2020

Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score

The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).

Start: January 2018

Mild Hypothermia and Acute Kidney Injury in Liver Transplantation

Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. The study will evaluate if mild hypothermia protects from AKI during liver transplantation.

Start: July 2018