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

Rush University Medical Center300 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

300

Conditions

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

Interventions

AminophyllineDRUG

75 mg of intravenous aminophylline

PlaceboDRUG

Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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®).

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Diarrhea (as Reported by the Patient)

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.

Time frame: Within 2 hours from the intervention

Secondary Outcomes

Number of Patients With Any (One or More) Regadenoson-related Adverse-effect

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.

Time frame: Within 2 hours from the intervention.

Global Symptom Score (GSS) of Regadenoson Related Adverse-effects

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

Time frame: Within 2 hours from the intervention.

Patients With Recorded Aminophylline Related Major Adverse Events

Aminophylline related adverse effects include: systemic hypotension (systolic blood pressure \< 90 mmHg), any thachyarrhythmia (ventricular or supraventricular) and seizure.

Time frame: Within 24 hours from the intervention.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.