Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging

Phase 4 Completed 300 enrolled Rush University Medical Center Cook County Health · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The routine administration of 75 mg of intravenous aminophylline in patients with severe chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.

Timeline

Start: 2011-06
Primary completion: 2012-05
Completion: 2012-05

Outcome

Met primary endpoint

paper In the aminophylline arm, there was 65% reduction in the incidence of the primary endpoint of diarrhea (9 (6.0%) vs. 26 (17.3%), P = 0.002) PMID 23224354 ↗

Publications

Doukky R, Rangel MO, Dick R, Wassouf M, Alqaid A, Margeta B. Attenuation 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. Int J Cardiovasc Imaging. 2013 Jun;29(5):1029-37. doi: 10.1007/s10554-012-0166-6. Epub 2012 Dec 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aminophylline	Small molecule	75 mg	Intravenous

Indications

No indication recorded.