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 (ASSUAGE-CKD Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diarrhea (as Reported by the Patient)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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®).
研究组 & 干预措施
Aminophylline
75 mg of intravenous aminophylline.
干预措施: Aminophylline (Drug)
Placebo
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
干预措施: Placebo (Drug)
结局指标
主要结局
Diarrhea (as Reported by the Patient)
时间窗: 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.
次要结局
- Number of Patients With Any (One or More) Regadenoson-related Adverse-effect(Within 2 hours from the intervention.)
- Global Symptom Score (GSS) of Regadenoson Related Adverse-effects(Within 2 hours from the intervention.)
- Patients With Recorded Aminophylline Related Major Adverse Events(Within 24 hours from the intervention.)
研究者
Rami Doukky
Director of Nuclear Cardiology and Stress Testing Laboratories
Rush University Medical Center