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Clinical Trials/NCT01023451
NCT01023451
Completed
Not Applicable

Serum Brain Natriuretic Peptide Levels and Its Correlation With Echocardiographic Measurements Suggestive of Pulmonary Hypertension in Pediatric Patients With Sickle Cell Disease

Akron Children's Hospital1 site in 1 country21 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension
Sponsor
Akron Children's Hospital
Enrollment
21
Locations
1
Primary Endpoint
Correlation of Brain Natriuretic Peptide (BNP) levels to elevated Tricuspid Regurgitation Flow Velocity (TRV)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is

  1. To determine if Brain natriuretic peptide levels correlates with elevated tricuspid regurgitation flow velocity levels in pediatric patients with sickle cell disease
  2. To determine the role of age, gender, steady state hemoglobin and disease type on Brain natriuretic peptide levels and pulmonary hypertension

Detailed Description

Pulmonary hypertension is recognized as a significant cause of morbidity and mortality in patients with sickle cell disease. Doppler echocardiography is a recommended noninvasive screening tool for sickle cell disease patients with pulmonary hypertension. Brain natriuretic peptide levels have been found to be a possible serum screening marker. This research will offer the opportunity to determine if there is any possible relationship between magnitude of BNP concentration and degree of TRV, if it can be used as a screening test in SCD pediatric patients with PHT and form the basis for a future multicenter study

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
June 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male and Female any age
  • Diagnosis of SCD with PHT on echocardiogram
  • Controls must have a diagnosis of sickle cell disease without Pulmonary hypertension, age, gender and disease type match to subjects with pulmonary hypertension
  • Parent or Legal guardian willing to sign informed consent form

Exclusion Criteria

  • Abnormal echocardiograms not related to PHT
  • Parent or Legal guardian unwilling or unable to give written informed consent

Outcomes

Primary Outcomes

Correlation of Brain Natriuretic Peptide (BNP) levels to elevated Tricuspid Regurgitation Flow Velocity (TRV)

Time Frame: one day

Subjects will be asked to participate in the study by allowing a review of their echocardiographic findings. In addition, they will be asked for a 1 ml blood sample during routine annual follow ups for BNP levels to be drawn.

Study Sites (1)

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