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Fig. 1 | Cardiovascular Diabetology

Fig. 1

From: Rationale and design of an investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized trial to evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease (FIVE-STAR)

Fig. 1

Study design. CAVI, cardio ankle vascular index; eGFR, estimated glomerular filtration rate; T2D, type 2 diabetes; UACR, urinary albumin-to-creatinine ratio. 1 If the date of discontinuation is within the allowance of each visit, observation and examination will be performed to the extent possible. 2 In principle, baseline testing should be conducted within 60 days of obtaining consent, and study drug dosing should begin thereafter. 3 Height, weight, office and home blood pressure (optional), and office and home pulse rate (optional). Data after obtaining consent will be prioritized. However, data within 3 months prior to obtaining consent can be used. Height will be measured at baseline only. 4 Serum creatinine and eGFR alone. 5 Serum pentosidine, urinary type IV collagen, urinary α1-microglobulin, β2-microglobulin, urinary neutrophil gelatinase-associated lipocalin, N-acetyl-β-d-glucosaminidase, and urinary liver-type fatty acid-binding protein corrected by urinary creatinine. 6 Hemoglobin, hematocrit, serum albumin and potassium, HbA1c, plasma (or serum) aldosterone concentration, and plasma (or serum) renin activity (or concentration). 7 Serum potassium alone. 8 Serum potassium and HbA1c alone. 9 Serum potassium, HbA1c, plasma (or serum) aldosterone concentration, and plasma (or serum) renin activity (or concentration) alone

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