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- Ruilope, LM, et al.
(author)
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Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial
- 2019
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In: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
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Journal article (peer-reviewed)abstract
- <b><i>Background:</i></b> Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. <b><i>Patients and</i></b> <b><i>Methods:</i></b> The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m<sup>2</sup> and albuminuria (urinary albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. <b><i>Conclusions:</i></b> FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.
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| 2. |
- Ferreira, Mjv, et al.
(author)
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Poster Session 3 : Tuesday 5 May 2015, 08
- 2015
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In: European Heart Journal Cardiovascular Imaging. - : Oxford University Press (OUP). - 2047-2404 .- 2047-2412. ; 16 Suppl 1
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Journal article (peer-reviewed)
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- Antzutkin, Oleg, et al.
(author)
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Binding of Aluminium(III)-Citrate Complexes, [Al3(H-1Cit)3(OH)]-4 and [Al3(H-1Cit)3(OH)4]-7, to Alzheimer's A-beta(1-40) Peptides : In situ Atomic Force, Electron Microscopy and Solid State 13C and 27Al NMR Studies
- 2005
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In: Sixth Keele Meeting on Aluminium. - : Centro de Estudos do Ambiente e Mar, Universidade de Aveiro. ; , s. 16-
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Conference paper (other academic/artistic)abstract
- It is believed that Alzheimer's disease (AD) amyloid-β-peptide (Aβ) deposits contribute directly to the disease's progressive neurodegeneration. Aggregation cascade for Aβ peptides, its relevance to neurotoxicity in the course of AD, various factors modulating Aβ aggregation kinetics and experimental methods useful for these studies were recently discussed [1]. Al(III), Zn(II), Cu(II) and Fe(III) ions are often colocalized at the center of the core of Alzheimer's amyloid plaques [2] and are suggested to promote aggregation of physiological concentrations of Aβ [3]. It has also been suggested that Al can block calcium permeable putative Aβ-peptide channels in bilayer membranes [4]. Therefore studies of complexation of metal ions with Aβ-oligomers and fibrils are important in the search for the causes of and potential treatments for AD.We studied effects of highly soluble and biologically relevant aluminium(III)-citrate compounds, [Al3(H-1Cit)3(OH)]-4 and [Al3(H-1Cit)3(OH)4]-7, on the fibrillogenesis of Aβ(1-40). All resonances in 156.37 MHz 27Al and 90.52 MHz 13C MAS NMR spectra of powder Al(III)-citrate complexes were assigned. 27Al MAS NMR of dialysed samples of Aβ(1-40) co-incubated with the Al(III)-citrate complexes at different concentrations in TRIS buffer solutions, pH 7.4, shows that Al(III)-citrates bind to Aβ(1-40) as [Al3(H-1Cit)3(OH)]-4 and either accelerate ([Al3(H-1Cit)3(OH)]-4 complex) or retard ([Al3(H-1Cit)3(OH)4]-7 compound) aggregation of Aβ(1-40) as revealed by AFM. [1] ON Antzutkin, Magn. Reson. Chem. 42 (2004) 231; [2] MA Lovell et al., J. Neurol. Sci. 158 (1998) 47; Ch Exley et al., Al and Alzheimer's disease, Ch Exley (Ed)1998) 47; Ch Exley , Ch Exley (Ed) Elsevier Science, 2001, 421; [3] PW Mantyh et al., J. Neurochem. 61 (1993) 1171; [4] N Arispe et al, PNAS 90 (1993) 567.
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| 6. |
- Bachnick, Stefanie, et al.
(author)
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TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) Project : Protocol for an International Longitudinal Multicenter Study
- 2024
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In: JMIR Research Protocols. - 1929-0748. ; 13
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Journal article (peer-reviewed)abstract
- BACKGROUND: Nursing-sensitive events (NSEs) are common, accounting for up to 77% of adverse events in hospitalized patients (eg, fall-related harm, pressure ulcers, and health care-associated infections). NSEs lead to adverse patient outcomes and impose an economic burden on hospitals due to increased medical costs through a prolonged hospital stay and additional medical procedures. To reduce NSEs and ensure high-quality nursing care, appropriate nurse staffing levels are needed. Although the link between nurse staffing and NSEs has been described in many studies, appropriate nurse staffing levels are lacking. Existing studies describe constant staffing exposure at the unit or hospital level without assessing patient-level exposure to nurse staffing during the hospital stay. Few studies have assessed nurse staffing and patient outcomes using a single-center longitudinal design, with limited generalizability. There is a need for multicenter longitudinal studies with improved potential for generalizing the association between individual nurse staffing levels and NSEs.OBJECTIVE: This study aimed (1) to determine the prevalence, preventability, type, and severity of NSEs; (2) to describe individual patient-level nurse staffing exposure across hospitals; (3) to assess the effect of nurse staffing on NSEs in patients; and (4) to identify thresholds of safe nurse staffing levels and test them against NSEs in hospitalized patients.METHODS: This international multicenter study uses a longitudinal and observational research design; it involves 4 countries (Switzerland, Sweden, Germany, and Iran), with participation from 14 hospitals and 61 medical, surgery, and mixed units. The 16-week observation period will collect NSEs using systematic retrospective record reviews. A total of 3680 patient admissions will be reviewed, with 60 randomly selected admissions per unit. To be included, patients must have been hospitalized for at least 48 hours. Nurse staffing data (ie, the number of nurses and their education level) will be collected daily for each shift to assess the association between NSEs and individual nurse staffing levels. Additionally, hospital data (ie, type, teaching status, and ownership) and unit data (ie, service line and number of beds) will be collected.RESULTS: As of January 2024, the verification process for the plausibility and comprehensibility of patients' and nurse staffing data is underway across all 4 countries. Data analyses are planned to be completed by spring 2024, with the first results expected to be published in late 2024.CONCLUSIONS: This study will provide comprehensive information on NSEs, including their prevalence, preventability, type, and severity, across countries. Moreover, it seeks to enhance understanding of NSE mechanisms and the potential impact of nurse staffing on these events. We will evaluate within- and between-hospital variability to identify productive strategies to ensure safe nurse staffing levels, thereby reducing NSEs in hospitalized patients. The TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) study will focus on the optimization of scarce staffing resources.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56262.
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