Adults 6 to 65, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Frequency of the Diffuse Myocardial Fibrosis PhenotypePrimary· Assessed annually over a 2-year period (3 assessments over 2 years)
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.
Group
Value
95% CI
Stratum A (6-13.99 Years)
5
Stratum B (14-20.99 Years)
10
Stratum C (≥21 Years)
10
Stratum D (Early Treatment)
1
Stability of the Diffuse Myocardial Fibrosis Phenotype Over TimeSecondary· Assessed annually over a 2-year period (3 assessments over 2 years)
The occurrence of a change \[from the baseline assessment\] in the classification \[presence or absence\] of the diffuse myocardial fibrosis phenotype, which is defined as an abnormally increased extracellular volume (ECV) measurement as assessed by cardiac magnetic resonance imaging (CMR) using T1 mapping before and after administration of gadolinium. Expressed as number of participants who had a change in classification of the diffuse myocardial fibrosis phenotype \[e.g., presence to absence, or absence to presence\] during the 2-year study in each stratum.
Group
Value
95% CI
Stratum A (6-13.99 Years)
0
Stratum B (14-20.99 Years)
0
Stratum C (≥21 Years)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs were collected for three, separate 30-day intervals over the entire study period of 2 years. Each 30-day interval was defined as starting with the study visit during which annual study activities were performed (e.g., cardiac magnetic resonance imaging [CMR]) and ending 30 days after that study visit. AEs were assessed as they occurred during each study visit, and AEs that occurred in the 30 days after each study visit were collected by scripted phone call from the study team..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
Last refreshed: 2 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02410811.