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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01598441

Enrollment

Registered

2012-05-15

Start date

2012-06-30

Completion date

2016-11-30

Last updated

2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension, pulmonary hypertensive crisis

Brief summary

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

Primary objectives: 1. To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD. 2. To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD. Secondary objectives: 1. 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. 2. To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD.

Interventions

DRUGiloprost nebuliser solution

Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days

DRUGdistilled water

1-2 ml aerosolized distilled water inhalation per session

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

7 Days to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The total incidence of RPH, PHC or death	within 48 hours after surgery	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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026