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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 (ASSUAGE-CKD)

This study has been completed.
Sponsor:
Collaborator:
John H. Stroger Hospital
Information provided by (Responsible Party):
Rami Doukky, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01336140
First received: April 11, 2011
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
Results First Received: December 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson (Lexiscan ®).
Interventions: Drug: Aminophylline
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited in the period from June 14, 2011 to May 14, 2012 in the stress testing laboratories of Rush University medical center and John H. Stroger, Jr. Hospital of Cook County (Chicago, IL.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
427 patients were recruited. 122 patients were excluded: 50 refused; 35 met an exclusion criteria; 1 was previously enrolled in the trial; 26 had a contraindication to aminophylline. 5 consenting subjects were excluded: 3 had their regadenoson-stress clinically cancelled; 2 treatment assignment could not be verified (labeling error).

Reporting Groups
  Description
Aminophylline 75 mg of intravenous aminophylline.
Placebo Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Participant Flow:   Overall Study
    Aminophylline     Placebo  
STARTED     150     150  
COMPLETED     150     150  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Aminophylline 75 mg of intravenous aminophylline.
Placebo Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Total Total of all reporting groups

Baseline Measures
    Aminophylline     Placebo     Total  
Number of Participants  
[units: participants]
 		  150     150     300  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     125     111     236  
>=65 years     25     39     64  
Age  
[units: years]
Mean ± Standard Deviation 		  54  ± 13     56  ± 13     55  ± 13  
Gender  
[units: participants]
 		     
Female     53     54     107  
Male     97     96     193  
Region of Enrollment  
[units: participants]
 		     
United States     150     150     300  



  Outcome Measures
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1.  Primary:   Diarrhea (as Reported by the Patient)   [ Time Frame: Within 2 hours from the intervention ]
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2.  Secondary:   Number of Patients With Any (One or More) Regadenoson-related Adverse-effect   [ Time Frame: Within 2 hours from the intervention. ]
  Show Outcome Measure 2

3.  Secondary:   Global Symptom Score (GSS) of Regadenoson Related Adverse-effects   [ Time Frame: Within 2 hours from the intervention. ]
  Show Outcome Measure 3

4.  Secondary:   Patients With Recorded Aminophylline Related Major Adverse Events   [ Time Frame: Within 24 hours from the intervention. ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None  


Results Point of Contact:  
Name/Title: Rami Doukky
Organization: Rush University Medical center
phone: 312-942-4655
e-mail: rami_doukky@rush.edu


No publications provided


Responsible Party: Rami Doukky, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01336140     History of Changes
Other Study ID Numbers: ASSUAGE-CKD, 110129
Study First Received: April 11, 2011
Results First Received: December 2, 2012
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration