Clinical trial NCT01336140: Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson
Keywords: regadenoson
chronic kidney disease
renal failure
lexiscan
aminophylline
SPECT
Myocardial Perfusion Imaging
pharmacologic stress test
Patients with stage IV or V chronic kidney disease being assessed with nuclear stress testing of the heart using the stress agent regadenoson (Lexiscan ®)
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Cook County Health
First posted: 2011-04-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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®).

Primary outcomes:
measure: Diarrhea (as Reported by the Patient)
timeFrame: Within 2 hours from the intervention
Secondary outcomes:
measure: Number of Patients With Any (One or More) Regadenoson-related Adverse-effect
timeFrame: Within 2 hours from the intervention.
measure: Global Symptom Score (GSS) of Regadenoson Related Adverse-effects
timeFrame: Within 2 hours from the intervention.
measure: Patients With Recorded Aminophylline Related Major Adverse Events
timeFrame: Within 24 hours from the intervention.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Rami Doukky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doukky R, Rangel MO, Dick R, Wassouf M, Alqaid A, Margeta B. 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--the ASSUAGE-CKD trial. Int J Cardiovasc Imaging. 2013 Jun;29(5):1029-37. doi: 10.1007/s10554-012-0166-6. Epub 2012 Dec 11.