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

Phase 4

Completed

Conditions: Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson

Brief 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.

Detailed Description: Approximately 300 patients with severe chronic kidney disease who are referred for a nuclear stress testing of the heart with regadenoson (Lexiscan®) will be recruited to participate in the study. Following regadenoson (administered as part of a stress routine test protocol) participants will receive either aminophylline (75 mg - intravenously) or a matching inactive placebo (sterile salt water) injection. Participants will be surveyed for gastrointestinal symptoms and other side effects related to regadenoson. The frequency and severity of such side effects will be compared between the two study groups (aminophylline vs. placebo).

Recruitment & Eligibility

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®).

Arm && Interventions

Group	Intervention	Description
Aminophylline	Aminophylline	75 mg of intravenous aminophylline.
Placebo	Placebo	Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Primary Outcome Measures

Name	Time	Method
Diarrhea (as Reported by the Patient)	Within 2 hours from the intervention	Number of patients who report any incident of diarrhea. Patients will be surveyed for incidents of diarrhea following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory (typically within 2 hours from stress completion). The primary endpoint encompasses the number of patients with reported symptoms of diarrhea, not the number of bowel movements.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Any (One or More) Regadenoson-related Adverse-effect	Within 2 hours from the intervention.	Regadenoson-related adverse-effects include: flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea. When multiple adverse effects are reported, only one event is counted.
Global Symptom Score (GSS) of Regadenoson Related Adverse-effects	Within 2 hours from the intervention.	GSS is the sum of severity-weighted (0 = none, 1 = mild, 2 = moderate, 3 = severe) regadenosnon-related adverse-effects of flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea. GSS is calculated by weighting each side effect from 0 - 3 (as above) then add the severity weighted scores of all adverse effects (total of 10 as above). The number of adverse effects contributing to the score is 10, each has a potential severity weight of 0 (absent) to 3 (severe). Thus: Minimum possible Global Symptom Score (GSS) = 0 Maximum possible Global Symptom Score (GSS) = 30
Patients With Recorded Aminophylline Related Major Adverse Events	Within 24 hours from the intervention.	Aminophylline related adverse effects include: systemic hypotension (systolic blood pressure \< 90 mmHg), any thachyarrhythmia (ventricular or supraventricular) and seizure.