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Regadenoson for Heart Transplant Rejection
Study Summary
This trial will use MRI and cell sequencing to look for early evidence of heart transplant rejection and determine the underlying causes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have uncontrolled asthma or COPD.I have had seizures that affect my whole body.I am 18 years old or older.I had a heart transplant more than three months ago.I had a biopsy showing acute rejection in the last 3 months.I have had heart attack symptoms or a heart attack in the last 3 months.I have a problem with my heart's natural pacemaker.My kidney function is low, with a GFR under 30.I've had bad reactions to specific heart or MRI tests.I have severe claustrophobia.
- Group 1: Normal graft function
- Group 2: Cardiac allograft vasculopathy
- Group 3: ACR/AMR
- Group 4: Nonspecific allograft dysfunction
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are being welcomed into this trial?
"Affirmative, the clinical trial is still recruiting participants according to clinicaltrials.gov's records. This investigation was originally posted on October 1st 2019 and recently updated on November 3rd 2021 with a goal of enrolling 376 patients from one medical facility."
Is this pioneering clinical trial the first of its kind?
"Clinical studies of regadenoson commenced in 2014, with Astellas Scientific & Medical Affairs, Inc. sponsoring the first trial involving 300 participants. Subsequently approved by Phase 4 drug approval, 7 current trials are ongoing across 6 distinct countries and 12 cities."
Has the U.S Food and Drug Administration (FDA) validated the use of Regadenoson?
"Regadenoson is proven to be safe as evidenced by its Phase 4 status, and thus earned a score of 3 on our 1-3 scale."
Are there any other documented instances of Regadenoson being tested as a treatment?
"Presently, 7 clinical trials are researching the effects of Regadenoson with 0 conducted in Phase 3. Multiple locations across the United States are participating, particularly around Houston Texas; 20 sites total have been identified as possible places to conduct this medical research."
Are there any vacancies available in this clinical trial?
"This clinical trial, which was initially published on October 1st 2019 and revised November 3rd 2021 according to the information found at clinicaltrials.gov is actively looking for participants."
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