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Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Wendy M. Book, Emory University
ClinicalTrials.gov Identifier:
NCT00308230
First received: March 27, 2006
Last updated: July 16, 2014
Last verified: July 2014
Results First Received: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Congenital Heart Disease
Cardiovascular Disease
Interventions: Procedure: Six minute walk test
Behavioral: Minnesota Living with Heart Failure Questionnaire

  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
medical specialty clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

No washout or run-in period. Participants were stable Ambulatory outpatients with no changes in their medical regimen for prior to enrollment.

Exclusions included inability to complete a six minute walk, inability to cooperate with instructions, congenital diagnosis other than the three listed in the CHD group (TOF, DTGA, CCTGA)


Reporting Groups
  Description
Control Group Structurally normal heart without heart disease.
Congenital Heart Disease Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
Heart Failure Acquired left ventricular heart failure, no history of congenital heart disease

Participant Flow:   Overall Study
    Control Group     Congenital Heart Disease     Heart Failure  
STARTED     6     8     20  
COMPLETED     6     8     20  
NOT COMPLETED     0     0     0  



  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
Control Structurally normal heart without heart disease
Congenital Heart Disease Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
Heart Failure Acquired left ventricular heart failure, no history of congenital heart disease
Total Total of all reporting groups

Baseline Measures
    Control     Congenital Heart Disease     Heart Failure     Total  
Number of Participants  
[units: participants]
  6     8     20     34  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     6     8     20     34  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     4     3     4     11  
Male     2     5     16     23  



  Outcome Measures

1.  Primary:   BNP Levels   [ Time Frame: 1 day ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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: Wendy Book
Organization: Emory University
phone: 404-778-5545
e-mail: wbook@emory.edu


No publications provided


Responsible Party: Wendy M. Book, Emory University
ClinicalTrials.gov Identifier: NCT00308230     History of Changes
Other Study ID Numbers: IRB00045884
Study First Received: March 27, 2006
Results First Received: September 10, 2013
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration