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

This study has been completed.
Sponsor:
Collaborator:
Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery
Information provided by (Responsible Party):
Xu Zhuoming, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01598441
First received: May 6, 2012
Last updated: November 20, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
Pulmonary Hypertension
Drug: iloprost nebuliser solution
Drug: distilled water
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • The total incidence of RPH, PHC or death [ Time Frame: within 48 hours after surgery ] [ Designated as safety issue: No ]

    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:
  • Change from base line of pulmonary hemodynamic measurements [ Time Frame: within 48 hours after surgery ] [ Designated as safety issue: No ]
    • Pp/Ps
    • NYHA class function
    • SvO2
    • PAO2


Enrollment: 8
Study Start Date: June 2012
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598441

Locations
China, Guangdong
Guangzhou Children's Hospital
Guangzhou, Guangdong, China, 510000
China, Hubei
Wuhan Asia Hear Hospital
Wuhan, Hubei, China, 430022
China
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
Investigators
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 
Study First Received: May 6, 2012
Last Updated: November 20, 2016
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on December 02, 2016