Trial Outcomes & Findings for Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients (NCT NCT03231371)

Results Overview

Ratio of peak to baseline coronary flow velocity (CFV)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

22 participants

Primary outcome timeframe

Baseline testing (acute only), 3 minutes of adenosine infusion

Results posted on

2017-09-26

Participant milestones
Measure	Study Arm Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
Overall Study STARTED	22
Overall Study Optional and Age Limited (12 Yrs+) MRI	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	13

Reasons for withdrawal
Measure	Study Arm Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
Overall Study Withdrawal by Subject	1
Overall Study chose or were ineligible to have MRI	12

Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients

Baseline characteristics by cohort
Measure	Study Arm n=22 Participants Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
Age, Customized 1-18 years	14 Participants n=5 Participants
Age, Customized 18 - 25 years	8 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

Timeframe: Baseline testing (acute only), 3 minutes of adenosine infusion

Population: Remaining subjects (of the 21 who completed) had unusable signal data.

Ratio of peak to baseline coronary flow velocity (CFV)

Outcome measures
Measure	Study Arm n=17 Participants Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
Coronary Flow Reserve (CFR)	1.77 ratio: peak to baseline CFV Standard Deviation 2.62

Timeframe: Baseline MRI only

Population: Only 9 participants had MRI data available. Remaining subjects (of 21) did not undergo MRI performed within study time frame.

Categorical measure - yes or no; number of participants with gadolinium enhancement

Outcome measures
Measure	Study Arm n=9 Participants Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
Gadolinium Enhancement by Cardiac MRI	4 Participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Study Arm n=22 participants at risk Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
Cardiac disorders Transient Atrial Ventricular block, self-resolved without intervention	18.2% 4/22 • Number of events 7 • 72 hours post infusion

University of Michigan