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Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xu Zhuoming, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01320878
First received: March 22, 2011
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

The objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects.


Condition Intervention Phase
Pulmonary Hypertension
Drug: iloprost nebuliser solution
Drug: distilled water
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • all cause pulmonary artery pressure [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • central venous pressure [ Time Frame: one year ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: one year ] [ Designated as safety issue: No ]
  • cardiac index [ Time Frame: one year ] [ Designated as safety issue: No ]
  • pulmonary vascular resistance [ Time Frame: one year ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: iloprost low dose group
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
Drug: iloprost nebuliser solution
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
Other Name: Ventavis
Active Comparator: iloprost high dose group
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
Drug: iloprost nebuliser solution
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
Other Name: Ventavis
Placebo Comparator: placebo group
distilled water 2 ml per session
Drug: distilled water
distilled water 2 ml per session
Other Name: Treeful

Detailed Description:

Pulmonary hypertension is a serious postoperative complication in children with congenital heart defects, which has a high incidence and mortality. Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels, without side affecting the systemic circulation. No randomized controlled trials (RCT) of iloprost have previously been performed in this indication. The investigators study is the first RCT of iloprost for inhalation after surgery of children's congenital heart diseases to be performed in this field.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Before corrective procedure for CHD, two of bellow ten criteria should be met:

  • Decreased respiratory infection & decreased exercise tolerance
  • Pulse SaO2 < 93% in left-right shunt CHD case (in room air)
  • EKG: right ventricular hypertrophy, right atrial dilatation
  • Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessel in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement
  • Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt
  • Underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels
  • Pp/Ps > 0.75
  • Qp/Qs <1.5
  • PVR > 9WU/m2
  • Rp/Rs > 0.5

Exclusion Criteria:

  • a body weight of < 2 kg,
  • prematurity (birth 36 weeks postconceptual age)
  • renal dysfunction (creatinine >= 1.5 mg/dL 48 hours before surgery)
  • PLT < 50,000*109/L and obvious bleeding
  • LCOS or hypotension on arrival to the intensive care unit

After corrective procedure for CHD:

  • deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
  • severe arrhythmia led to low cardiac output
  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: NCT01320878

Locations
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
Investigators
Study Director: Zhuo-ming Xu, MD,PhD Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
  More Information

Publications:
Responsible Party: Xu Zhuoming, Director of Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center., Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01320878     History of Changes
Other Study ID Numbers: SJTUMS-10-16
Study First Received: March 22, 2011
Last Updated: June 15, 2012
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014