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

Pulmonary Hypertension Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598441
• Other study ID #: SCMCIRB-201127
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2012
• Last updated: November 20, 2016
• Start date: June 2012
• Est. completion date: November 2016

Study information

• Verified date: January 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Diseases
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• iloprost nebuliser solution
Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
• distilled water
1-2 ml aerosolized distilled water inhalation per session

Locations

Country	Name	City	State
China	Guangzhou Children's Hospital	Guangzhou	Guangdong
China	Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center	Shanghai
China	Wuhan Asia Hear Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from base line of pulmonary hemodynamic measurements	Pp/Ps; NYHA class function; SvO2; PAO2	within 48 hours after surgery	No