Serum Brain Natriuretic Peptide Levels and Pulmonary Hypertension in Pediatric Sickle Cell Patients - Full Text View

Purpose

The purpose of this study is

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

Condition
Pulmonary Hypertension

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
Official Title:	Serum Brain Natriuretic Peptide Levels and Its Correlation With Echocardiographic Measurements Suggestive of Pulmonary Hypertension in Pediatric Patients With Sickle Cell Disease

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension Sickle Cell Anemia

Drug Information available for: Nesiritide

U.S. FDA Resources

Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:

Correlation of Brain Natriuretic Peptide (BNP) levels to elevated Tricuspid Regurgitation Flow Velocity (TRV) [ Time Frame: one day ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	20
Study Start Date:	December 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	7 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Sickle cell clinic

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023451

Locations

United States, Ohio
Akron Children's Hospital Sickle Cell Clinic
Akron, Ohio, United States, 44308

Sponsors and Collaborators

Akron Children's Hospital

Investigators

Principal Investigator:	Stephanie Do, DO	Akron Children's Hospital
Principal Investigator:	Jeffrey Hord, MD	Akron Children's Hospital

More Information

Publications:

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.

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.

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.

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.

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. Epub 2002 Oct 3.

Responsible Party:	Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT01023451 History of Changes
Other Study ID Numbers:	091007
Study First Received:	December 1, 2009
Last Updated:	December 13, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:

Pulmonary hypertension
Sickle cell disease
Pediatric patients
Brain Natriuretic Peptide levels

Additional relevant MeSH terms:

Anemia, Sickle Cell
Hypertension
Hypertension, Pulmonary
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Vascular Diseases

Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013