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Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network

This study has been completed.
Sponsor:
Collaborators:
Pediatric Heart Network
Information provided by:
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00115934
First received: June 26, 2005
Last updated: August 2, 2013
Last verified: August 2013
Results First Received: September 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Defects, Congenital
Interventions: Procedure: Blalock-Taussig pulmonary artery shunt
Procedure: Right ventricular to pulmonary artery shunt

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects undergoing a Norwood were randomized to MBTS or RVPAS at 15 North American centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no pre-assignment requirements beyond the initial screening criteria.

Reporting Groups
  Description
MBTS Blalock-Taussig pulmonary artery shunt
RVPAS Right ventricular to pulmonary artery shunt

Participant Flow:   Overall Study
    MBTS     RVPAS  
STARTED     279 [1]   276 [2]
COMPLETED     275     274  
NOT COMPLETED     4     2  
Lost to Follow-up                 1                 0  
Did not receive intervention                 3                 2  
[1] 279 randomized to MBTS, but 3 did not have a Norwood surgery; one was withdrawn-with limited data.
[2] 276 randomized to RVPAS, but 2 did not have a Norwood surgery and were excluded from analyses.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MBTS Blalock-Taussig pulmonary artery shunt
RVPAS Right ventricular to pulmonary artery shunt
Total Total of all reporting groups

Baseline Measures
    MBTS     RVPAS     Total  
Number of Participants  
[units: participants]
  275     274     549  
Age  
[units: participants]
     
<=18 years     275     274     549  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: days]
Mean ± Standard Deviation
  5.1  ± 4.1     5.0  ± 4.0     5.1  ± 4.0  
Gender  
[units: participants]
     
Female     107     102     209  
Male     168     172     340  
Region of Enrollment  
[units: participants]
     
United States     268     266     534  
Canada     7     8     15  



  Outcome Measures
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1.  Primary:   Proportion of Patients Who Died or Received a Heart Transplant   [ Time Frame: Measured at 12 months ]

2.  Secondary:   Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial   [ Time Frame: From Randomization to the End of the Trial, an average of 32 months ]

3.  Secondary:   Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)   [ Time Frame: Measured post-Norwood, an average of 17 days post-Norwood ]

4.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA   [ Time Frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery ]

5.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA   [ Time Frame: Measured at 14 months of age ]

6.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA   [ Time Frame: Measured post-Norwood, an average of 17 days post-Norwood ]

7.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA   [ Time Frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery ]

8.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA   [ Time Frame: Measured at 14 months of age ]

9.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction   [ Time Frame: Measured post-Norwood, an average of 17 days post-Norwood ]

10.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction   [ Time Frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery ]

11.  Secondary:   Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction   [ Time Frame: Measured at 14 months of age ]

12.  Secondary:   Angiographic Findings: Left Pulmonary Artery Size   [ Time Frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation ]

13.  Secondary:   Angiographic Findings: Right Pulmonary Artery Size   [ Time Frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation ]

14.  Secondary:   Unintended Cardiovascular Interventional Procedures   [ Time Frame: From Randomization to 12 months ]

15.  Secondary:   Complications: Total Number Experienced During Norwood Hospitalization   [ Time Frame: Norwood Hospitalization, an average of 36 days ]

16.  Secondary:   Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge   [ Time Frame: From Norwood Discharge to Stage II discharge, an average of 4.2 months ]

17.  Secondary:   Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age   [ Time Frame: From Stage II Discharge to 14 Months of Age, an average of 8.9 months ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented.
Additional Description Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
MBTS Blalock-Taussig pulmonary artery shunt
RVPAS Right ventricular to pulmonary artery shunt

Other Adverse Events
    MBTS     RVPAS  
Total, other (not including serious) adverse events      
# participants affected / at risk     249/275     251/274  
Blood and lymphatic system disorders      
Hematologic † 1    
# participants affected / at risk     48/275 (17.45%)     57/274 (20.80%)  
# events     64     73  
Cardiac disorders      
Cardiac disorders † 1    
# participants affected / at risk     161/275 (58.55%)     148/274 (54.01%)  
# events     316     266  
Gastrointestinal disorders      
Gastrointestinal † 1    
# participants affected / at risk     93/275 (33.82%)     94/274 (34.31%)  
# events     138     133  
Infections and infestations      
Infectious † 1    
# participants affected / at risk     156/275 (56.73%)     172/274 (62.77%)  
# events     313     401  
Nervous system disorders      
Neurological † 1    
# participants affected / at risk     35/275 (12.73%)     53/274 (19.34%)  
# events     51     77  
Renal and urinary disorders      
Renal † 1    
# participants affected / at risk     39/275 (14.18%)     27/274 (9.85%)  
# events     41     28  
Respiratory, thoracic and mediastinal disorders      
Respiratory † 1    
# participants affected / at risk     154/275 (56.00%)     172/274 (62.77%)  
# events     285     387  
Vascular disorders      
Vascular † 1    
# participants affected / at risk     32/275 (11.64%)     34/274 (12.41%)  
# events     34     38  
Events were collected by systematic assessment
1 Term from vocabulary, PHN coding dictionar



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
As in all surgical trials comparing two operations, it was not possible to blind the personnel caring for the subjects to the intervention. However, the components of the primary endpoint, death and transplantation, are discrete objective events.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lynn Sleeper, ScD
Organization: New England Research Institutes
phone: 617-972-3235
e-mail: lsleeper@neriscience.com


Publications of Results:

Other Publications:
Publications automatically indexed to this study:


Responsible Party: Lynn Sleeper, ScD, PI, New England Research Institutes, Watertown, MA
ClinicalTrials.gov Identifier: NCT00115934     History of Changes
Other Study ID Numbers: 194, U01HL068270, U01HL068269, U01HL068279, U01HL068281, U01HL068285, U01HL068288, U01HL068290, U01HL068292
Study First Received: June 26, 2005
Results First Received: September 14, 2010
Last Updated: August 2, 2013
Health Authority: United States: Federal Government