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

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ClinicalTrials.gov Identifier: NCT01598441
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: iloprost nebuliser solution Drug: distilled water Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Study Start Date : June 2012
Primary Completion Date : November 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: iloprost
Iloprost nebuliser solution 500 ng/kg inhaled
Drug: iloprost nebuliser solution
Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
Other Name: Ventavis
Placebo Comparator: distilled water
aerosolized distilled water 1-2 ml
Drug: distilled water
1-2 ml aerosolized distilled water inhalation per session
Other Name: Treeful

Outcome Measures

Primary Outcome Measures :
  1. The total incidence of RPH, PHC or death [ Time Frame: 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 Outcome Measures :
  1. Change from base line of pulmonary hemodynamic measurements [ Time Frame: within 48 hours after surgery ]
    • Pp/Ps
    • NYHA class function
    • SvO2
    • PAO2

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598441

China, Guangdong
Guangzhou Children's Hospital
Guangzhou, Guangdong, China, 510000
China, Hubei
Wuhan Asia Hear Hospital
Wuhan, Hubei, China, 430022
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery
Principal Investigator: Zhuomin Xu, PhD Shanghai Jiao Tong University School of Medicine
More Information

Responsible Party: Xu Zhuoming, Director of ICU, Department of thoracic and cardiovascular surgery, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01598441     History of Changes
Other Study ID Numbers: SCMCIRB-201127
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: January 2016

Keywords provided by Xu Zhuoming, Shanghai Jiao Tong University School of Medicine:
pulmonary hypertension, pulmonary hypertensive crisis

Additional relevant MeSH terms:
Heart Diseases
Hypertension, Pulmonary
Heart Defects, Congenital
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Pharmaceutical Solutions
Platelet Aggregation Inhibitors
Vasodilator Agents