N/A
N=33
Novel Cardiac Magnetic Resonance Imaging to Define a Unique Restrictive Cardiomyopathy in Sickle Cell Disease
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT02410811 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Frequency of the Diffuse Myocardial Fibrosis Phenotype — 5; 10; 10; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cardiac magnetic resonance imaging (CMR) (Other)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of the Diffuse Myocardial Fibrosis Phenotype |
5; 10; 10; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Sickle cell anemia (HbSS) or sickle-β°-thalassemia (HbSβ°) confirmed by hemoglobin separation and identification techniques
- Ability to cooperate with and undergo CMR without sedation or anesthesia.
- Ability to cooperate with and undergo echocardiogram
- Written informed consent in accordance with the institutional policies and federal guidelines must be provided by the participant (if ≥18 years of age) or parent or legally authorized guardian (if the participant is 6 consecutive months since the initiation of disease-modifying therapy.
Exclusion Criteria
- Any contraindication to MRI or physical or behavioral factor that could degrade the quality of MRI data or interfere with a participant's tolerance of the MRI, such as permanent or semi-permanent metallic implants, including pacemakers and defibrillators, or severe claustrophobia
- Known ventricular septal defect (VSD) documented in medical record
- Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 (estimated by serum creatinine or cystatin-C)
- Pregnancy (documented by serum or urine pregnancy test)
The following additional inclusion criterion applies to strata A, B and C only:
- Current chronic transfusion therapy (defined as regular, approximately monthly, transfusions of packed red blood cells given for at least 6 consecutive months for the treatment of prevention of SCD-related complications with the plan to continue this therapy at the time of potential enrollment).
Data sourced from ClinicalTrials.gov (NCT02410811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.