Trials / Completed
CompletedNCT01336140
Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging
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)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Rush University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aminophylline | 75 mg of intravenous aminophylline |
| DRUG | Placebo | Matching 0.9 Normal Saline (sterile salt water)administered intravenously. |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2012-05-01
- Completion
- 2012-05-01
- First posted
- 2011-04-15
- Last updated
- 2023-01-26
- Results posted
- 2013-02-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01336140. Inclusion in this directory is not an endorsement.