NCT02410811|CompletedResults
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Sponsor study identifier
observational
33
1 country
1
Study Start
January 31, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 29, 2018
Actual (reported)Study Completion
May 20, 2019
Actual (reported)The purpose of this study is to use cardiac magnetic resonance imaging (CMR) and echocardiographic tissue Doppler imaging to demonstrate a unique restrictive cardiomyopathy of sickle cell disease. The investigators will characterize its frequency and how it might change (e.g., presence/absence and severity) over a 2-year period.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 2, 2014
Actual (reported)April 8, 2015
Actual (reported)January 29, 2018
Actual (reported)May 20, 2019
Actual (reported)November 2, 2020
Actual (reported)Frequency of the Diffuse Myocardial Fibrosis Phenotype
The occurrence of an abnormally increased extracellular volume (ECV) measurement \[i.e., the presence of the diffuse myocardial fibrosis phenotype\] as assessed by cardiac magnetic resonance imaging (CMR) using T1 mapping before and after administration of gadolinium. Expressed as number of participants with the diffuse myocardial fibrosis phenotype in each stratum.
Assessed annually over a 2-year period (3 assessments over 2 years)
Stability of the Diffuse Myocardial Fibrosis Phenotype Over Time
Assessed annually over a 2-year period (3 assessments over 2 years)
* Age 6 to 13.99 years * Cardiac magnetic resonance imaging (CMR)
* Age 14 to 20.99 years * Detectible and quantifiable TRJV with reported value * Cardiac magnetic resonance imaging (CMR)
* Age ≥21 years * Detectible and quantifiable TRJV with reported value * Cardiac magnetic resonance imaging (CMR)
* Age ≥6 years. * Current use of disease-modifying therapy \[hydroxyurea, chronic transfusions, or both (given concurrently, sequentially, or both)\] that was initiated at \<3 years of age, and for which there has been no interruption of therapy for \>6 consecutive months since the initiation of disease-modifying therapy. * Cardiac magnetic resonance imaging (CMR)
CMR is obtained on all participants in all arms/groups
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Enrolling a maximum of 40 participants in the entire study across four age strata: A, 6 - 13.9 years; B, 14 - 20.9 years; C, 21 years and older; and D, 6 years and older.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Powell AW, Alsaied T, Niss O, Fleck RJ, Malik P, Quinn CT, Mays WA, Taylor MD, Chin C. Abnormal submaximal cardiopulmonary exercise parameters predict impaired peak exercise performance in sickle cell anemia patients. Pediatr Blood Cancer. 2019 Jun;66(6):e27703. doi: 10.1002/pbc.27703. Epub 2019 Mar 7.
Alsaied T, Niss O, Powell AW, Fleck RJ, Cnota JF, Chin C, Malik P, Quinn CT, Taylor MD. Diastolic dysfunction is associated with exercise impairment in patients with sickle cell anemia. Pediatr Blood Cancer. 2018 Aug;65(8):e27113. doi: 10.1002/pbc.27113. Epub 2018 May 21.
Blood, DNA, and urine specimens.
All participants in strata A, B and C had severe diffuse myocardial fibrosis. That is, all participants had the phenotype for which we assessed, so correlative studies (e.g., affected vs. non-affected) could not be performed. Therefore, we amended the protocol and opened an additional, fourth stratum (D) to study individuals who were previously not eligible for inclusion.
Charles T Quinn, M.D.
Children's Hospital Medical Center, Cincinnati
Michael D Taylor, MD
Children's Hospital Medical Center, Cincinnati
Robert J Fleck, M.D.
Children's Hospital Medical Center, Cincinnati
Omar Y Niss, M.D.
Children's Hospital Medical Center, Cincinnati
33 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2014
First Posted
April 8, 2015
Study Start
January 31, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease
Contact the study team to confirm eligibility.
Niss O, Fleck R, Makue F, Alsaied T, Desai P, Towbin JA, Malik P, Taylor MD, Quinn CT. Association between diffuse myocardial fibrosis and diastolic dysfunction in sickle cell anemia. Blood. 2017 Jul 13;130(2):205-213. doi: 10.1182/blood-2017-02-767624. Epub 2017 May 15.
Niss O, Quinn CT, Lane A, Daily J, Khoury PR, Bakeer N, Kimball TR, Towbin JA, Malik P, Taylor MD. Cardiomyopathy With Restrictive Physiology in Sickle Cell Disease. JACC Cardiovasc Imaging. 2016 Mar;9(3):243-52. doi: 10.1016/j.jcmg.2015.05.013. Epub 2016 Feb 17.
Niss O, Morin CE, Hashemi S, Alsaied T, Lang SM, Taylor MD, Tasset M, Malik P, Quinn CT. Longitudinal changes and predictors of cardiac extracellular volume fraction in sickle cell anemia. Blood Red Cells Iron. 2025 Dec;1(3):100031. doi: 10.1016/j.brci.2025.100031. Epub 2025 Nov 20.
Primary Completion
January 29, 2018
Actual (reported)Study Completion
May 20, 2019
Actual (reported)Last Updated
November 2, 2020
Results First Posted
November 2, 2020
Record last verified: 2019-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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