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
  Purpose

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.


Condition Intervention Phase
Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson (Lexiscan ®).
Drug: Aminophylline
Drug: Placebo
Phase 4

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
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)

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Diarrhea (as Reported by the Patient) [ Time Frame: Within 2 hours from the intervention ] [ Designated as safety issue: No ]

    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 [ Time Frame: Within 2 hours from the intervention. ] [ Designated as safety issue: No ]

    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 [ Time Frame: Within 2 hours from the intervention. ] [ Designated as safety issue: No ]

    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 [ Time Frame: Within 24 hours from the intervention. ] [ Designated as safety issue: Yes ]
    Aminophylline related adverse effects include: systemic hypotension (systolic blood pressure < 90 mmHg), any thachyarrhythmia (ventricular or supraventricular) and seizure.


Enrollment: 300
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aminophylline
75 mg of intravenous aminophylline.
Drug: Aminophylline
75 mg of intravenous aminophylline
Placebo Comparator: Placebo
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Drug: Placebo
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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®).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336140

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
John H. Stroger Hospital
Investigators
Principal Investigator: Rami Doukky, MD Rush University Medical Center
  More Information

No publications provided by Rush University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rami Doukky, Director of Nuclear Cardiology and Stress Testing Laboratories, 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

Keywords provided by Rush University Medical Center:
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 ®)

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Aminophylline
Regadenoson
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cardiotonic Agents
Cardiovascular Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists

ClinicalTrials.gov processed this record on August 20, 2014