Phase 4
Completed N=300
Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging
Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson
Source: ClinicalTrials.gov NCT01336140 ↗
Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Diarrhea (as Reported by the Patient) — 9; 26 participants — p=0.002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diarrhea (as Reported by the Patient) |
9; 26 | 0.002 sig |
| SECONDARY Number of Patients With Any (One or More) Regadenoson-related Adverse-effect |
47; 96 | < 0.001 sig |
| SECONDARY Global Symptom Score (GSS) of Regadenoson Related Adverse-effects |
1.7; 2.1 | < 0.001 sig |
| SECONDARY Patients With Recorded Aminophylline Related Major Adverse Events |
0; 0 | 1 |
Eligibility Criteria
Inclusion Criteria
- Adult patients referred to undergo a clinically-indicated regadenoson-stress myocardial perfusion imaging at Rush University Medical Center
- Stage IV or V chronic kidney disease (GFR < 30, hemodialysis, and/or peritoneal dialysis).
Exclusion Criteria
- Patient refusal to participate
- Known allergic reaction to aminophylline.
- Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea, abdominal discomfort, nausea or vomiting.
- Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and acute coronary symptoms.
- Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12 months or any seizure in the past week.
- Pregnant or breast-feeding women.
- Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).
Data sourced from ClinicalTrials.gov (NCT01336140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.