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- Ruilope, LM, et al.
(författare)
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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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Ingår i: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
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Tidskriftsartikel (refereegranskat)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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- Jaarsma, Tiny, et al.
(författare)
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Effects of exergaming on exercise capacity in patients with heart failure : results of an international multicentre randomized controlled trial
- 2021
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Ingår i: European Journal of Heart Failure. - : John Wiley & Sons. - 1388-9842 .- 1879-0844. ; 23:1, s. 114-124
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Tidskriftsartikel (refereegranskat)abstract
- AimsExergaming is a new tool to increase physical activity. This study aimed to determine the effects of access to a home‐based exergame (Nintendo Wii) in patients with heart failure (HF) on exercise capacity, self‐reported physical activity and patient‐reported outcome measures.Methods and resultsWe enrolled 605 HF patients in New York Heart Association functional class I–IV, independent of ejection fraction, in an international multicentre randomized controlled trial. Patients were randomized to exergame (intervention) or motivational support (control). The primary endpoint was change in submaximal aerobic exercise capacity as measured by the distance walked in 6 min (6MWT) between baseline and 3 months. Secondary endpoints included long‐term submaximal aerobic exercise capacity, muscle function, self‐reported physical activity, exercise motivation, exercise self‐efficacy at 3, 6 and 12 months. At baseline, patients on average walked 403 ± 142 m on the 6MWT. Patients in the exergame group walked further compared to controls at 3 months (454 ± 123 vs. 420 ± 127 m, P = 0.005), at 6 months (452 ± 123 vs. 426 ± 133 m, P = 0.015) and 12 months (456 ± 122 vs. 420 ± 135 m, P = 0.004). However, correcting for baseline 6MWT values by means of a linear mixed‐effects model revealed no main effect for the intervention on 6MWT. Small significant effects on muscle function were found. Statistically significant treatment effects were found for muscle function but after correction for baseline and confounders, only the treatment effect for the heel‐rise left at 6 months was significant (P < 0.05). No treatment effect was found for exercise motivation, exercise self‐efficacy, or self‐reported physical activity.ConclusionExergaming was safe and feasible in patients with HF with different profiles in different health care systems, cultures and climates. However, it was not effective in improving outcomes on submaximal aerobic exercise capacity. Subgroup analysis did not identify specific subgroups benefiting from the intervention.
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