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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT01023451
First received: December 1, 2009
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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

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:


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.


Enrollment: 21
Study Start Date: December 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: June 24, 2014
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 July 31, 2014