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New treatment option for Heart Transplant Failure and Rejection
Official title Allograft Dysfunction in Heart Transplant
ClinicalTrials.gov ID: NCT03102125
What this study is testing
What is Regadenoson?
Regadenoson is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for heart transplant failure and rejection.
Also referred to as Lexiscan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 60 months
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age greater than or equal to 18 years old.
- At least three months status post heart transplantation.
You likely 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.
See the full eligibility criteria
- Age greater than or equal to 18 years old.
- At least three months status post heart transplantation.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 60 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.