Orthotopic Heart Transplant
Conditions
Keywords
Orthotopic Heart Transplant
Brief summary
Heart transplantation is a life-sustaining therapy that allows patients with either congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time, however, the transplanted heart can develop problems. One of the more common and troubling problems is the development of stenoses, or narrowings, within the coronary arteries. These narrowings, technically referred to as coronary artery vasculopathy (CAV for short), account for the single most common cause of death or need for repeat heart transplant in persons more than one year post-transplant. Traditionally, CAV has been diagnosed at cardiac catheterization using coronary angiography (where dye is directly injected into the coronary blood vessels and viewed using special x-ray equipment called fluoroscopy). There is no good treatment for CAV aside from treatment of symptoms and listing for repeat heart transplantation. The goal of this study is to test several newer methods of diagnosing CAV. The first is called coronary flow reserve (catheterization test). The second is called Endo-PAT (a finger probe test) and the third is called contrast-enhanced cardiac MRI (MRI test, only for patients 12 and older). The older method (coronary angiography) will still be used in all cases, in addition to the new tests The goal is, one day, to be able to diagnose patients with CAV earlier in the course, prior to a patient's development of abnormal angiograms. If this can be done, it is possible that better therapies will be able to be used to stop or even reverse the development of CAV, perhaps reducing, or at least delaying, the need for repeat heart transplantation.
Interventions
DRUGAdenosine
Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
Sponsors
Bryan Goldstein
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Patients age 1 - 25 years who are status-post OHT (≤18 years at the time of transplantation) and undergoing routine post-transplant surveillance catheterization for endomyocardial biopsy and coronary angiography
Exclusion criteria
* The presence of sick sinus syndrome or 2nd or 3rd degree atrioventricular block (without a functioning implanted pacemaker) * Hemodynamically significant valvular disease * Severe asthma or bronchospasm, known severe CAV * Pulmonary hypertension. * Patients taking digoxin * Verapamil and dipyridamole are also excluded given known interactions with adenosine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary Flow Reserve (CFR) | Baseline testing (acute only), 3 minutes of adenosine infusion | Ratio of peak to baseline coronary flow velocity (CFV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gadolinium Enhancement by Cardiac MRI | Baseline MRI only | Categorical measure - yes or no; number of participants with gadolinium enhancement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Arm Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose). | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | chose or were ineligible to have MRI | 12 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Study Arm |
|---|---|
| Age, Customized 1-18 years | 14 Participants |
| Age, Customized 18 - 25 years | 8 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Coronary Flow Reserve (CFR)
Ratio of peak to baseline coronary flow velocity (CFV)
Time frame: Baseline testing (acute only), 3 minutes of adenosine infusion
Population: Remaining subjects (of the 21 who completed) had unusable signal data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Arm | Coronary Flow Reserve (CFR) | 1.77 ratio: peak to baseline CFV | Standard Deviation 2.62 |
Secondary
Gadolinium Enhancement by Cardiac MRI
Categorical measure - yes or no; number of participants with gadolinium enhancement
Time frame: Baseline MRI only
Population: Only 9 participants had MRI data available. Remaining subjects (of 21) did not undergo MRI performed within study time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Arm | Gadolinium Enhancement by Cardiac MRI | 4 Participants |