Study With Aminophylline to Attenuate of the Side Effects of Regadenoson

Summary

The routine administration of 75 mg of intravenous aminophylline following regadenoson (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce the gastrointestinal (diarrhea and stomach upset) and other side effects related to regadenoson.

Timeline

Start

2010-11

Primary completion

2011-11

Completion

2011-11

Outcome

Met primary endpoint

Stopped (Enrollment): “Due to nationwide shortage of Aminophylline. Enrolled subjects did not complete study.”

paper primary endpoint of diarrhea and abdominal discomfort [11 (8.9%) vs 22 (17.7%), P = .04] PMID 22395779 ↗

Publications

• Results Doukky R, Morales Demori R, Jain S, Kiriakos R, Mwansa V, Calvin JE. Attenuation of the side effect profile of regadenoson: a randomized double-blinded placebo-controlled study with aminophylline in patients undergoing myocardial perfusion imaging. "The ASSUAGE trial". J Nucl Cardiol. 2012 Jun;19(3):448-57. doi: 10.1007/s12350-012-9533-x. Epub 2012 Mar 7.
• Ballany W, Mansour K, Morales Demori R, Al-Amoodi M, Doukky R. The impact of regimented aminophylline use on extracardiac radioisotope activity in patients undergoing regadenoson stress SPECT myocardial perfusion imaging: a substudy of the ASSUAGE trial. J Nucl Cardiol. 2014 Jun;21(3):496-502. doi: 10.1007/s12350-014-9864-x. Epub 2014 Feb 12.

Drugs

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

Indications

No indication recorded.