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Alprostadil 5 MCG Injection for Congenital Heart Disease (Alprostadil Trial)

Phase 1

Waitlist Available

Led By Rajiv Chaturvedi, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up will be measured 30 minutes to 40 minutes after infusion of alprostadil

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial investigates the effects of Alprostadil on children who have had heart surgery. Alprostadil helps widen blood vessels, which can improve blood flow to the lungs. This is important for children with low lung blood flow and poor oxygen levels after their surgery. Alprostadil is a naturally occurring substance used to help infants with heart issues until further surgery can be performed.

Eligible Conditions

Congenital Heart Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will be measured 30 minutes to 40 minutes after infusion of alprostadil

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will be measured 30 minutes to 40 minutes after infusion of alprostadil

This trial's timeline: 3 weeks for screening, Varies for treatment, and will be measured 30 minutes to 40 minutes after infusion of alprostadil for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cerebral blood flow

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

1. Baseline cardiac catheterization under GA. (Standard of Care, SOC) 2. Transfer patient to MRI unit 3. Baseline MRI 1. Obtain ABG for pCO2 from existing femoral arterial access. 2. Repeat pressure measurements with existing catheters at the SVC, RA and Aorta. 3. MRI phase contrast imaging for flow measurements(SOC). 4. During the MRI, Alprostadil infusion will be started and titrated to the target dose 0.1mcg/kg/min, provided there is a less than 20% drop in blood pressure from baseline. 5. Post alprostadil infusion 1. 1ml blood sample taken from existing femoral venous access for prostaglandin level. 2. Repeat pressure measurements with existing catheters left at the SVC, RA and Aorta. 3. Repeat MRI flow measurements 7.Return to cath lab if further intervention required. 8.Recovery and monitoring for 4 to 6 hours prior to discharge(SOC).

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