Back to resultsAttenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging (ASSUAGE-CKD)
Primary Purpose
Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aminophylline
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson focused on measuring 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 ®)
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®).
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aminophylline
Placebo
Arm Description
75 mg of intravenous aminophylline.
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
Full Information
NCT ID
NCT01336140
First Posted
April 11, 2011
Last Updated
January 3, 2023
Sponsor
Rush University Medical Center
Collaborators
Cook County Health
1. Study Identification
Unique Protocol Identification Number
NCT01336140
Brief Title
Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging
Acronym
ASSUAGE-CKD
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Cook County Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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 ®)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aminophylline
Arm Type
Experimental
Arm Description
75 mg of intravenous aminophylline.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Aminophylline
Intervention Description
75 mg of intravenous aminophylline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Primary Outcome Measure Information:
Title
Diarrhea (as Reported by the Patient)
Description
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 Outcome Measure Information:
Title
Number of Patients With Any (One or More) Regadenoson-related Adverse-effect
Description
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.
Title
Global Symptom Score (GSS) of Regadenoson Related Adverse-effects
Description
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.
Title
Patients With Recorded Aminophylline Related Major Adverse Events
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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®).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami Doukky, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23224354
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.
Results Reference
derived
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Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging
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