Heart Transplant Failure and RejectionDiagnostics and screeningGeneticsLongevityDrugPhase 4
What this study is
The investigators will evaluate for early evidence of cardiac allograft dysfunction by cardiac MRI and single cell sequencing to determine underlying molecular and macroscopic causes.
What's being tested
- Regadenoson
Intervention · DRUG
For use in stress myocardial perfusion imaging.
Study details
- Official title
- Defining Mechanisms for Cardiac Allograft Dysfunction to Improve Allograft Longevity and Survival in Heart-Transplant Patients
- Sponsor
- Paul Kim
- Conditions
- Heart Transplant Failure and Rejection
- Enrolling
- 376 people
- Starts
- 2019-10-01
- Est. completion
- 2027-01-02
- Design
- Single-blind, non-randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age greater than or equal to 18 years old.
- At least three months status post heart transplantation.
You can't join if
- Biopsy proven acute rejection episode in the past 3 months.
- Patients with symptoms or signs of acute myocardial ischemia or recent acute coronary syndrome in the past 3 months.
- Uncontrolled obstructive ventilatory disease including asthma and COPD.
- History of generalized tonic-clonic seizures.
- Second or third degree AV nodal block.
- Sinus node dysfunction.
- Contraindications to MRI including cardiovascular implantable electronic devices.
- Renal dysfunction with an estimated GFR less than 30 mL/min/1.73m2.
- Prior adverse reaction to either regadenoson or gadolinium contrast. Prior adverse reaction to adenosine or dipyridamole will be assessed on a case-by-case basis.
- Systolic blood pressure greater than 180 or less than 85 mmHg.
- Diastolic blood pressure greater than 120 or less than 40 mmHg.
- Resting heart rate greater than 120 or less than 45 beats per minute. - Severe claustrophobia.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 open- Recruiting
Study team
Sponsor
Paul Kim
Study ID 190053
Principal investigator
Paul Kim, MD
UC San Diego
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.