View clinical trials related to Renal Insufficiency, Chronic.
Filter by:This observational study is assessing the effects that arterial stiffness may have on patients with heart failure (HF) and chronic kidney disease (CKD). Arterial stiffness will be measured by assessing pulse wave velocity (PWV). Carotid- Femoral PWV is the gold standard in measuring arterial stiffness non- invasively. Many studies have shown increasing PWV is a predictor of cardiovascular events, but the significance of increasing PWV as a surrogate marker for the potential worsening (decompensation) of HF or CKD has not been explored. This study aims to investigate patients with HF and CKD by assessing PWV while in a decompensated state and again when in a stable condition after 4 weeks of discharge to investigate a link between decompensation and rise of arterial stiffness. The research team aim to recruit 120 patients in this study with 40 patients in each of the 3 groups- heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF) and acute kidney injury (AKI). All AKI patients would have had known CKD (stages 3a, 3b or 4). The study participants will be initially recruited in hospital while admitted in an acute state and tests including bloods, ECG, echocardiography and PWV will be performed. The tests (excluding echocardiography) will be repeated 4 weeks after discharge. There is no intervention in this study. The study seeks to improve the understanding of the role of the vasculature in the development of acute HF in the two common types- HFrEF and HFpEF. As CKD is a common comorbidity in heart failure patients we felt that a study of the behaviour of arterial stiffness in this cohort will add to this understanding. If arterial stiffness is found to be an important component of the HF syndrome therapeutic interest could be focused at managing arterial stiffness with novel therapy.
The best treatment of Chronic Kidney Disease (CKD) is facilitated by early detection, when the progression of the disease can be slowed down or stopped. Early treatment focuses on diet, exercise, lifestyle changes, treating risk factors (diabetes, hypertension, etc.) and administration of medications supporting kidney functions. However, once the glomerular filtration rate dropped below 15 ml/min/1.73m2, treatment with dialysis or a kidney transplant is required. Dialysis treatments come with a huge lifestyle management and economic burden to the patients as well as the healthcare systems. The challenges may be facilitated by usage of mobile applications that help the patients/caregivers and multidisciplinary team to manage the complexity of Peritoneal Dialysis (PD) treatment. Even though several mobile applications currently exist, they focus on certain limited aspects of health monitoring like diet or vitals and medical adherence like medication reminders. An application which would take a comprehensive all-in-one solution approach targeted towards managing kidney health is needed. The platform developed by AWAK Technologies consists of a Admin Portal, web-based Clinic Portal and a Patient Mobile Application. The App would allow patients/caregivers to enter treatment data related to their dialysis therapy, medication, symptoms and vital monitoring. It also allows them to communicate with their healthcare team via messaging and teleconsult. The study aims to evaluate the feasibility of using this mHealth platform in the clinical setting. Additionally, the clinical investigation seeks to obtain data for further development of the mHealth platform that will better fulfil the needs of patients and healthcare professionals.
In this observational study, data from the recent past of patients with type 2 diabetes mellitus and chronic kidney disease will be studied. Type 2 diabetes mellitus (T2DM) is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels. About half of people with T2DM also have a condition called chronic kidney disease (CKD). In people with CKD, the kidneys' ability to work as how it should decreases over time. In this study, researchers want to learn more about the CKD in T2DM patients in Alberta, Canada. This will help them to know the chances to improve the care of these patients. The researchers will look at the health information from adult men and women in Alberta who were diagnosed with T2DM before 2018 and visited a doctor to have check-ups in 2018. They will find out about how many of these people had CKD and how severe their CKD was. The researchers will collect data about the age and gender of these patients, how long they had T2DM and if they had other related medical problems. The researchers will also learn how these patients were treated based on their kidney condition and how much money was spent on these treatments. This study will collect information from the health records of about 270,000 patients with T2DM who were living in Alberta, Canada. This information will come from the Alberta Kidney Disease Network (AKDN) database. Besides this data collection, no further tests or examinations are planned in this study.
Background: CKD in patients with heart failure (HF) is common and associated with poor prognosis. Despite evidence of benefit with Renin-Angiotensin-Aldosterone-System inhibitor (RAASi) agents, they are avoided due to fear of hyperkalaemia. New potassium binders, e.g. Sodium Zirconium Cyclosilicate (SZC), reduce incidence of hyperkalaemia in CKD-HF patients and hence may help RAASi maximisation, which has not been investigated in an RCT. Purpose: The proposed study will randomise HFrEF patients with stable CKD 3-5 and serum potassium 5-5.0 mmol/L, to receive SZC or placebo while RAASi therapy is maximised. The aim of the study is to examine if SZC is superior to placebo in achieving maximal doses of ACEi/ARB, e.g. Ramipril 10 mg, Candesartan 32 mg; and mineralocorticoid receptor antagonist, e.g. Epleronone 50 mg or Spironolactone 50 mg, avoiding hyperkalaemia. Methods: Eligible patients with eGFR<60 mL/min/1.73m2, heart failure (EF<40%) on none/submaximal dose of RAASi will be randomised to receive 10g TDS of investigational medicinal product (IMP), either SZC or placebo, for 48 hours and in 10 or 5g OD guided by laboratory serum potassium (K+). Every two weeks the RAASi dose will be increased and IMP adjusted according to a strict protocol and guided by laboratory potassium and creatinine. The primary endpoint of the study is achievement of maximal dose of RAASi in randomised patients avoiding hyperkalaemia, i.e. K+≤5.6 mmol/L. Patients will be allowed to continue with RAASi maximisation to K+<6.0mmol/L. Patients will be tested at baseline and follow-up visits for hyperkalaemia, AKI, symptomatic hypotension and QT prolongation on ECG. Results: The study results will show if SZC is superior to placebo for RAASi maximisation in CKD-HF patients while maintaining safe levels of serum potassium without any adverse impact on quality of life. The study will demonstrate if SZC allows higher RAASi dose and more dose escalations than placebo. It will also examine the impact of RAASi escalation on creatinine, proteinuria, and cardiac blood biomarkers. Conclusion: If positive, the results of this study will demonstrate that SZC enables RAASi up titration in CKD-HF patients, which potentially can help achieve optimal treatment and improve quality of life of the patient.
Assess the prevalence and features of left ventricular hypertrophy in patients with chronic kidney disease (CKD) taking into account gender differences and stage of CKD. To detect factors those predict LVH in CKD. *to assess the right ventricle dysfunction in CKD .
The report of the Epidemiological and Information Network in Nephrology counted 44,978 hemodialysis patients in France in 2017, with more than 93% of them attending 3 sessions per week. This multi-weekly recourse to the healthcare system in the context of substitution treatment constantly reminds patients of their disease and has a strong impact on their quality of life. The 2011 REIN quality of life report showed that the quality of life of patients with renal failure, particularly dialysis patients, is impaired, particularly in its physical and mental components. A recent comparative study (van Sandwijk et al., 2019) comparing hemodialysis patients with hematological cancer patients under chemotherapy supports these data. The June 2013 report of the "Etats généraux du rein", an initiative of patient associations, called for the improvement of quality of life to be made a priority and for the possibility of using supportive care and complementary non-drug techniques to be proposed. Socio-aesthetic care, defined "as the practice of aesthetic care for people who are suffering or vulnerable", has found its place in hospitals as a complementary discipline to medical care, particularly in oncology. We believe that in order to improve the overall quality of life of hemodialysis patients, the quality of the experience of each session must be improved. In this perspective, the repetition of socio-aesthetic care performed during dialysis sessions could contribute to the overall improvement of the quality of life. A national survey (Saghatchian et al., 2018) on the impact of socio-aesthetic care in oncology confirms the positive perception of this care among cancer patients. Two studies carried out in hemodialysis (Bullen et al., 2018; Unal & Balci Akpinar, 2016) using complementary techniques, such as acupuncture, massage, or foot reflexology, highlight an impact on sleep, fatigue and quality of life. The experience of implementing socio-aesthetic care in our hemodialysis unit also leads us to believe that they positively influence the perception of the session, and therefore perhaps the quality of life measured with a validated scale, the KDQOL (Kidney Disease Quality Of Life). Our research therefore focuses on the effectiveness of social and aesthetic care during hemodialysis sessions to improve the quality of life of the hemodialysis patient.
Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating. No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice. The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to: 1. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice 2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design 3. Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent. The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve patient informed consent.
Obesity is at risk for the development of chronic kidney disease but the involved mechanisms are not known (Navarro et al. 2015). Establishing the link between obesity and kidney damage is difficult. Indeed, kidney function measurement lacks precision in obese people (Lemoine et al. 2014) and requires expensive methods such as measurement of 99mTc-DTPA clearance. Biopsies are too invasive for the detection of emerging kidney damage or for the following of the kidney function. Therefore new tools are required for the early identification of at risk individuals for the kidney damage complication. Mesenchymal stem cells may represent such a relevant tool. These cells are present in a large number of organs, including kidney (Costa et al. 2020). In addition to be differentiated cells progenitors (Dominici et al. 2006), they also support immunosuppressive, anti-fibrotic and pro-angiogenic functions that have been used for the treatment of kidney fibrosis (Usunier et al. 2014). Therefore, mesenchymal stem cells contribute to tissue homeostasis and their alterations may reflect organ dysfunctions. Indeed, mesenchymal stem cells from obese adipose tissue lose their immunosuppressive (Serena et al. 2016) and differentiation (Gustafson et al. 2009) functions and contribute to fibrosis (Keophiphath et al. 2009) and inflammation (Lee et al. 2010; Gustafson, Nerstedt, et Smith 2019). It is thus probable that kidney dysfunctions are associated with functional alterations of kidney mesenchymal stem cells. The collection of mesenchymal stem cells from kidney can easily be performed from urine and next cultivated for amplification. They are called urine stem cells (USC). From our experience with obese mouse adipose stem cells, we observed that functional changes of stem cells preceded adipose tissue dysfunctions. Functional signatures of mesenchymal stem cells are thus representative of changes occuring in the function of the tissue notably in answer to obesity. These features could be used to identify obese people presenting ongoing alterations of kidney function, before clinical manifestations of kidney dysfunction. Because kidney mesenchymal stem cells are easy to isolate from urine, their collection is compatible with the follow up of patients and can be applied to a large number of individuals, including the younger. USC could represent a valuable tool to detect progression towards kidney damage. In this project we plan to analyse USC alterations induced by obesity and to identify signatures associated with the progression towards kidney damage and type 2 diabetes. The goal is to evaluate USC as potential marker for the non invasive monitoring of patients in answer to a need that is not achieved by the present available approaches.
The study is being conducted to evaluate the efficacy, and safety of Paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults.
The study will have 2 independent parts: Part 1 of the study is intended to collect samples for Metabolites in Safety Testing (MIST) analysis after administration of multiple doses of zibotentan. Part 2 of the study is designed to evaluate the relative bioavailability of zibotentan and dapagliflozin after dosing with two different fixed-dose combination (FDC) formulations and dosing with separate formulations of zibotentan and dapagliflozin.