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

NCT01336140 | Completed Phase 4 Results DMC

• 2 other identifiers: ASSUAGE-CKD110129
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

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 ®)

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 2 hours from the intervention

Secondary Outcomes (3)

• Number of Patients With Any (One or More) Regadenoson-related Adverse-effect

  Within 2 hours from the intervention.

• Global Symptom Score (GSS) of Regadenoson Related Adverse-effects

  Within 2 hours from the intervention.

• Patients With Recorded Aminophylline Related Major Adverse Events

  Within 24 hours from the intervention.

Study Arms (2)

Aminophylline

EXPERIMENTAL

75 mg of intravenous aminophylline.

Drug: Aminophylline

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Aminophylline DRUG

75 mg of intravenous aminophylline

Aminophylline

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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®).

Sponsors & Collaborators

• Rush University Medical Center: lead
• Cook County Health: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 23224354 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

Aminophylline

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Rami Doukky
• Organization: Rush University Medical center

rami_doukky@rush.edu

312-942-4655

Study Officials

• Rami Doukky, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Cardiology and Stress Testing Laboratories

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 15, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 26, 2023
• Results First Posted: February 13, 2013

Record last verified: 2023-01

Locations

US (1)