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

Rush

Status and phase: Completed; Phase 4

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

Treatments: Drug: Placebo; Drug: Aminophylline

Study type: Interventional

Funder types: Other

Identifiers

NCT01336140

ASSUAGE-CKD

110129

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Aminophylline

Experimental group

Description:

75 mg of intravenous aminophylline.

Treatment:

Drug: Aminophylline

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo