Pulmonary HypertensionNCT01023451
Serum Brain Natriuretic Peptide Levels and Pulmonary Hypertension in Pediatric Sickle Cell Patients
An observational study of Pulmonary Hypertension, run by Akron Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Sickle cell clinic
Who may be able to join
- 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
Who cannot join
- Abnormal echocardiograms not related to PHT
- Parent or Legal guardian unwilling or unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Akron Children's Hospital Sickle Cell Clinic
Akron, Ohio, 44308
About this study
Official title: Serum Brain Natriuretic Peptide Levels and Its Correlation With Echocardiographic Measurements Suggestive of Pulmonary Hypertension in Pediatric Patients With Sickle Cell Disease
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
Read the 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
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary hypertension, Sickle cell disease, Pediatric patients, Brain Natriuretic Peptide levels
- Medical subject headings
- Hypertension, Pulmonary, Anemia, Sickle Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Brain Natriuretic Peptide (BNP) levels to elevated Tricuspid Regurgitation Flow Velocity (TRV)
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Do, DO, Principal investigator, Akron Children's HospitalJeffrey Hord, MD, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023451
- Sponsor's protocol ID
- 091007
- Status last verified
- Jun 2014
- First submitted
- 1 Dec 2009
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1056/NEJMoa035477.
PubMed 14985486Ataga 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.
PubMed 15501204Suell 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.
PubMed 16344670Nelson 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.
PubMed 17483714Castro 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.
PubMed 12393669
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Brain Natriuretic Peptide Levels and Its Correlation With Echocardiographic Measurements Suggestive of Pulmonary Hypertension in Pediatric Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT01023451
- Acronym / sponsor ID
- 091007
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary hypertension, Sickle cell disease, Pediatric patients, Brain Natriuretic Peptide levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Sickle cell clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Abnormal echocardiograms not related to PHT
- Parent or Legal guardian unwilling or unable to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Background: PubMed 14985486Gladwin 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.
- Background: PubMed 15501204Ataga 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.
- Background: PubMed 16344670Suell 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.
- Background: PubMed 17483714Nelson 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.
- Background: PubMed 12393669Castro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Do, DO principal investigator
Akron Children's Hospital
Jeffrey Hord, MD principal investigator
Akron Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Akron Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Brain Natriuretic Peptide (BNP) levels to elevated Tricuspid Regurgitation Flow Velocity (TRV) (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01023451, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.