The international journal of cardiovascular imaging
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Int J Cardiovasc Imaging · Jun 2013
Randomized Controlled Trial Multicenter StudyAttenuation of the side effect profile of regadenoson: a randomized double-blind placebo-controlled study with aminophylline in patients undergoing myocardial perfusion imaging and have severe chronic kidney disease--the ASSUAGE-CKD trial.
A subgroup analysis of the ASSUAGE trial suggested that the standardized intravenous aminophylline administration following regadenoson-stress leads to substantial attenuation of regadenoson adverse-effects in patients with severe chronic kidney disease (CKD). In a randomized, double-blinded, placebo-controlled clinical trial of patients with stage 4 and 5 CKD, we compared the frequency and severity of regadenoson adverse-effects in those who received 75 mg of intravenous aminophylline versus a matching placebo administered 90 s post-radioisotope injection. Consecutive 300 patients with severe CKD (36% women; 86% end-stage renal disease; age 55 (±13) years) were randomized to receive aminophylline (n = 150) or placebo (n = 150). ⋯ The stress protocol was better tolerated in the aminophylline group (P = 0.008). The quantitative summed difference score, as a measure of stress-induced ischemic burden, was similar between the study groups (P = 0.51). In conclusion, the routine standardized administration of intravenous aminophylline in patients with severe CKD substantially reduces the frequency and severity of the adverse-effects associated with regadenoson-stress without changing the ischemic burden. [NCT01336140].
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Int J Cardiovasc Imaging · Jun 2013
Randomized Controlled Trial Multicenter StudyA randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting β1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease.
The purpose of this study was to compare the safety and efficacy of the short-acting β1-receptor blocker, landiolol hydrochloride (0.06 and 0.125-mg/kg), to placebo during coronary computed tomography angiography (CTA) in a phase 2 dose-finding study. A total of 183 patients suspected of having ischemic cardiac disease and scheduled to undergo an invasive coronary angiography were randomized to groups treated with landiolol hydrochloride (0.06 or 0.125-mg/kg) or placebo. The heart rate, safety, and the performance of coronary diagnosis using landiolol hydrochloride were evaluated in a multicenter, double-blind, randomized, parallel study. ⋯ The proportion of correctly classified patients was significantly higher in the 0.125-mg/kg landiolol hydrochloride group than in the placebo group (73.6 vs. 50.0 %). Landiolol hydrochloride at doses of 0.06 and 0.125-mg/kg significantly decreased the heart rate compared with a placebo. The present findings suggest that landiolol hydrochloride is safe and useful at a dose of 0.125-mg/kg to improve coronary diagnostic performance during coronary CTA.