Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent RegadenosonPhase 4ASSUAGE-CKDNCT01336140

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

A Phase 4 study testing Aminophylline in people with Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson
What is being tested?: Aminophylline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 1 siteUnited States
Study dates: Jun 2011to May 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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®).

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

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)

Read the 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).

Conditions: Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson
Being tested: Aminophylline, Placebo
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 ®)
Medical subject headings: Renal Insufficiency, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AminophyllineDrug
75 mg of intravenous aminophylline
PlaceboDrug
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Study groups in NCT01336140
Study group	Role	What they receive
Aminophylline	Experimental	75 mg of intravenous aminophylline. Receives: Drug: Aminophylline
Placebo	Placebo comparator	Matching 0.9 Normal Saline (sterile salt water)administered intravenously. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 2 hours from the intervention

Secondary outcomes (3)

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.
Measured: Within 2 hours from the intervention.
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
Measured: Within 2 hours from the intervention.
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.
Measured: Within 24 hours from the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011May 2012

First posted15 Apr 2011 (estimated)
Study startJun 2011
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent RegadenosonStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01336140
Sponsor's protocol ID: ASSUAGE-CKD
Other IDs: 110129
Acronym: ASSUAGE-CKD
Status last verified: Jan 2023
First submitted: 11 Apr 2011
Last updated: 26 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23224354

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01336140
Acronym / sponsor ID: ASSUAGE-CKD / ASSUAGE-CKD
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
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Collaborators: Cook County Health
Study start: Jun 2011
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 15 Apr 2011 (estimated)
Results: Posted 13 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aminophylline	Experimental	Drug: Aminophylline75 mg of intravenous aminophylline.
Placebo	Placebo comparator	Drug: PlaceboMatching 0.9 Normal Saline (sterile salt water)administered intravenously.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aminophylline75 mg of intravenous aminophylline	Drug	Aminophylline
PlaceboMatching 0.9 Normal Saline (sterile salt water)administered intravenously.	Drug	Placebo

Primary outcome

Diarrhea (as Reported by the Patient)
Time frame: Within 2 hours from the intervention
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.

3 secondary outcomes

Number of Patients With Any (One or More) Regadenoson-related Adverse-effect
Time frame: Within 2 hours from the intervention.
Global Symptom Score (GSS) of Regadenoson Related Adverse-effects
Time frame: Within 2 hours from the intervention.
Patients With Recorded Aminophylline Related Major Adverse Events
Time frame: Within 24 hours from the intervention.

Results and safety

Results posted to the registry on 13 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aminophylline	150	150
Placebo	150	150

Primary outcome: Diarrhea (as Reported by the Patient)

Time frame: Within 2 hours from the intervention. Number. Unit: participants

Measure	Aminophylline n = 150	Placebo n = 150
Value	9	26

Aminophylline vs Placebo: p = 0.002, Chi-squared

Population analysed: All patients.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aminophylline	0 of 150 (0%)	0 of 150 (0%)	0 of 150
Placebo	0 of 150 (0%)	0 of 150 (0%)	0 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23224354Doukky 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rami Doukky, MD principal investigator

Rush University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diarrhea (as Reported by the Patient) (time frame: Within 2 hours from the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01336140, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.