Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)

Study Overview
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Brief Summary
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This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.

Detailed Description
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Primary objectives: To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD. To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD. Secondary objectives: To investigate the preventive effect of iloprost inhaled on the life-threatening PHC occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass. To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD.

Official Title
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Multi-centre, Randomized Study of Iloprost Inhaled in Preventing and Treating Reactive Pulmonary Hypertension (RPH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Diseases (CHD)

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Drug: iloprost nebuliser solution
* Drug: distilled water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHD children who have associated PH risk factors and have accepted biventricular repair Pp/Ps >= 0.75 (before surgery) or Pp/Ps >= 0.5 (after surgery) Exclusion Criteria: severe mitral stenosis obstructive drainage of pulmonary veins platelet count < 50,000,000,000/L & obvious bleeding

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iloprost<br>Iloprost nebuliser solution 500 ng/kg inhaled | Drug: iloprost nebuliser solution<br>* Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days<br>* Other names: Ventavis;|
| Placebo Comparator: distilled water<br>aerosolized distilled water 1-2 ml | Drug: distilled water<br>* 1-2 ml aerosolized distilled water inhalation per session<br>* Other names: Treeful;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total incidence of RPH, PHC or death | The primary effective endpoints are reached when any individual components of the primary composite endpoint occur: RPH lasting for more than 30 mintues; or PHC at any time; or death | within 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from base line of pulmonary hemodynamic measurements | Pp/Ps NYHA class function SvO2 PAO2 | within 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary hypertension, pulmonary hypertensive crisis