Trial Outcomes & Findings for Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging (NCT NCT01336140)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

300 participants

Primary outcome timeframe

Within 2 hours from the intervention

Results posted on

2023-01-26

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Aminophylline 75 mg of intravenous aminophylline.	Placebo Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Overall Study STARTED	150	150
Overall Study COMPLETED	150	150
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aminophylline n=150 Participants 75 mg of intravenous aminophylline.	Placebo n=150 Participants Matching 0.9 Normal Saline (sterile salt water)administered intravenously.	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	125 Participants n=5 Participants	111 Participants n=7 Participants	236 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	39 Participants n=7 Participants	64 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 13 • n=5 Participants	56 years STANDARD_DEVIATION 13 • n=7 Participants	55 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	54 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	96 Participants n=7 Participants	193 Participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants	150 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 2 hours from the intervention

Population: All patients.

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.

Outcome measures

Outcome measures
Measure	Aminophylline n=150 Participants 75 mg of intravenous aminophylline.	Placebo n=150 Participants Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Diarrhea (as Reported by the Patient)	9 participants	26 participants

SECONDARY outcome

Timeframe: Within 2 hours from the intervention.

Population: All patients.

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.

Outcome measures

Outcome measures
Measure	Aminophylline n=150 Participants 75 mg of intravenous aminophylline.	Placebo n=150 Participants Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Number of Patients With Any (One or More) Regadenoson-related Adverse-effect	47 Participants	96 Participants

SECONDARY outcome

Timeframe: Within 2 hours from the intervention.

Population: All patients.

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

Outcome measures

Outcome measures
Measure	Aminophylline n=150 Participants 75 mg of intravenous aminophylline.	Placebo n=150 Participants Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Global Symptom Score (GSS) of Regadenoson Related Adverse-effects	1.7 Global Symptom Score Standard Deviation 0.8	2.1 Global Symptom Score Standard Deviation 1.6

SECONDARY outcome

Timeframe: Within 24 hours from the intervention.

Population: All patients.

Aminophylline related adverse effects include: systemic hypotension (systolic blood pressure \< 90 mmHg), any thachyarrhythmia (ventricular or supraventricular) and seizure.

Outcome measures

Outcome measures
Measure	Aminophylline n=150 Participants 75 mg of intravenous aminophylline.	Placebo n=150 Participants Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Patients With Recorded Aminophylline Related Major Adverse Events	0 participant	0 participant

Adverse Events

Aminophylline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aminophylline n=150 participants at risk 75 mg of intravenous aminophylline.	Placebo n=150 participants at risk Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Cardiac disorders Tachyarrhythmia	0.00% 0/150 • 24 hours In addition to all-cause mortality, the following adverse effects (AEs) were monitored and reported: 1. Tachyarrhythmias: any tachyarrhythmia within the subsequent 24 hours, not present baseline 2. Hypotension: any event of systolic blood pressure =/\< 80 mmHg regardless of symptoms or systolic blood pressure =/\< 90 mmHg with symptoms (dizziness, lightheadedness, presyncope, or syncope) 3. seizures: any seizure event reported within the 24 hours following the initiation of the stress protocol	0.00% 0/150 • 24 hours In addition to all-cause mortality, the following adverse effects (AEs) were monitored and reported: 1. Tachyarrhythmias: any tachyarrhythmia within the subsequent 24 hours, not present baseline 2. Hypotension: any event of systolic blood pressure =/\< 80 mmHg regardless of symptoms or systolic blood pressure =/\< 90 mmHg with symptoms (dizziness, lightheadedness, presyncope, or syncope) 3. seizures: any seizure event reported within the 24 hours following the initiation of the stress protocol
Cardiac disorders Hypotension	0.00% 0/150 • 24 hours In addition to all-cause mortality, the following adverse effects (AEs) were monitored and reported: 1. Tachyarrhythmias: any tachyarrhythmia within the subsequent 24 hours, not present baseline 2. Hypotension: any event of systolic blood pressure =/\< 80 mmHg regardless of symptoms or systolic blood pressure =/\< 90 mmHg with symptoms (dizziness, lightheadedness, presyncope, or syncope) 3. seizures: any seizure event reported within the 24 hours following the initiation of the stress protocol	0.00% 0/150 • 24 hours In addition to all-cause mortality, the following adverse effects (AEs) were monitored and reported: 1. Tachyarrhythmias: any tachyarrhythmia within the subsequent 24 hours, not present baseline 2. Hypotension: any event of systolic blood pressure =/\< 80 mmHg regardless of symptoms or systolic blood pressure =/\< 90 mmHg with symptoms (dizziness, lightheadedness, presyncope, or syncope) 3. seizures: any seizure event reported within the 24 hours following the initiation of the stress protocol
Nervous system disorders Seizure	0.00% 0/150 • 24 hours In addition to all-cause mortality, the following adverse effects (AEs) were monitored and reported: 1. Tachyarrhythmias: any tachyarrhythmia within the subsequent 24 hours, not present baseline 2. Hypotension: any event of systolic blood pressure =/\< 80 mmHg regardless of symptoms or systolic blood pressure =/\< 90 mmHg with symptoms (dizziness, lightheadedness, presyncope, or syncope) 3. seizures: any seizure event reported within the 24 hours following the initiation of the stress protocol	0.00% 0/150 • 24 hours In addition to all-cause mortality, the following adverse effects (AEs) were monitored and reported: 1. Tachyarrhythmias: any tachyarrhythmia within the subsequent 24 hours, not present baseline 2. Hypotension: any event of systolic blood pressure =/\< 80 mmHg regardless of symptoms or systolic blood pressure =/\< 90 mmHg with symptoms (dizziness, lightheadedness, presyncope, or syncope) 3. seizures: any seizure event reported within the 24 hours following the initiation of the stress protocol

Other adverse events

Adverse event data not reported

Additional Information

Rami Doukky

Rush University Medical center

Phone: 312-942-4655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place