Biomarker Study for Heart Failure in Children With Single Ventricle Physiology (BHFSVP)
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ClinicalTrials.gov Identifier: NCT00571233 |
Recruitment Status
:
Completed
First Posted
: December 11, 2007
Last Update Posted
: May 14, 2015
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Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
Tracking Information | ||||
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First Submitted Date | December 5, 2007 | |||
First Posted Date | December 11, 2007 | |||
Last Update Posted Date | May 14, 2015 | |||
Study Start Date | February 2007 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Heart failure, as assessed by clinical scoring systems. [ Time Frame: Cross-sectional. We will obtain blood samples and assess for heart failure (function) concurrently when patients present to the Pediatric Heart Center ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT00571233 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
Echocardiographic indices. [ Time Frame: Cross-sectional ] | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Biomarker Study for Heart Failure in Children With Single Ventricle Physiology | |||
Official Title | Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology | |||
Brief Summary | The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart. | |||
Detailed Description | We will investigate whether levels of blood proteins in children with well-functioning hearts with one ("single") ventricle are similar to levels of these blood proteins in children with two ventricles. For children with hearts with a single ventricle, we will examine blood proteins at various levels of heart function. To assess blood protein levels, we will collect small (6 mL) samples of blood. Heart function will be determined by existing clinical scoring systems. Enrolled patients will receive an echocardiogram, which is a dynamic ultrasound picture of the beating heart. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case Control Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Serum |
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Sampling Method | Non-Probability Sample | |||
Study Population | Patients presenting to the UCSF Pediatric Heart Center. | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
71 | |||
Original Estimated Enrollment |
40 | |||
Actual Study Completion Date | January 2015 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 1 Month to 6 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00571233 | |||
Other Study ID Numbers | 2529 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of California, San Francisco | |||
Study Sponsor | University of California, San Francisco | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | University of California, San Francisco | |||
Verification Date | May 2015 |