Serum Brain Natriuretic Peptide Levels and Pulmonary Hypertension in Pediatric Sickle Cell Patients

NCT ID: NCT01023451

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akron Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Do, DO

Role: PRINCIPAL_INVESTIGATOR

Akron Children's Hospital

Jeffrey Hord, MD

Role: PRINCIPAL_INVESTIGATOR

Akron Children's Hospital

Locations

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Akron Children's Hospital Sickle Cell Clinic

Akron, Ohio, United States

Site Status

Countries

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United States

References

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Gladwin MT, Sachdev V, Jison ML, Shizukuda Y, Plehn JF, Minter K, Brown B, Coles WA, Nichols JS, Ernst I, Hunter LA, Blackwelder WC, Schechter AN, Rodgers GP, Castro O, Ognibene FP. Pulmonary hypertension as a risk factor for death in patients with sickle cell disease. N Engl J Med. 2004 Feb 26;350(9):886-95. doi: 10.1056/NEJMoa035477.

Reference Type BACKGROUND
PMID: 14985486 (View on PubMed)

Ataga KI, Sood N, De Gent G, Kelly E, Henderson AG, Jones S, Strayhorn D, Lail A, Lieff S, Orringer EP. Pulmonary hypertension in sickle cell disease. Am J Med. 2004 Nov 1;117(9):665-9. doi: 10.1016/j.amjmed.2004.03.034.

Reference Type BACKGROUND
PMID: 15501204 (View on PubMed)

Suell MN, Bezold LI, Okcu MF, Mahoney DH Jr, Shardonofsky F, Mueller BU. Increased pulmonary artery pressures among adolescents with sickle cell disease. J Pediatr Hematol Oncol. 2005 Dec;27(12):654-8. doi: 10.1097/01.mph.0000194022.17968.bf.

Reference Type BACKGROUND
PMID: 16344670 (View on PubMed)

Nelson SC, Adade BB, McDonough EA, Moquist KL, Hennessy JM. High prevalence of pulmonary hypertension in children with sickle cell disease. J Pediatr Hematol Oncol. 2007 May;29(5):334-7. doi: 10.1097/MPH.0b013e31805d8f32.

Reference Type BACKGROUND
PMID: 17483714 (View on PubMed)

Castro O, Hoque M, Brown BD. Pulmonary hypertension in sickle cell disease: cardiac catheterization results and survival. Blood. 2003 Feb 15;101(4):1257-61. doi: 10.1182/blood-2002-03-0948. Epub 2002 Oct 3.

Reference Type BACKGROUND
PMID: 12393669 (View on PubMed)

Other Identifiers

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091007

Identifier Type: -

Identifier Source: org_study_id

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