Novel Cardiac Magnetic Resonance Imaging to Define a Unique Restrictive Cardiomyopathy in Sickle Cell Disease

Completed

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT02410811

Run by

Children's Hospital Medical Center, Cincinnati

People needed

33

Starts

2014-01-31

Expected to finish

2019-05-20

Last updated by the study team

2020-11-02

Who can join

Age: 6 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 <18 years of age) Minor participants ≥11 years of age will be requested to provide assent
• The following additional inclusion criterion applies to Age Stratum A:
• Age 6 to 13.99 years
• The following additional inclusion criteria apply to Age Stratum B:
• Age 14 to 20.99 years
• Detectible and quantifiable TRJV with reported value
• The following additional inclusion criteria apply to Age Stratum C:
• Age ≥21 years
• Detectible and quantifiable TRJV with reported value
• The following additional inclusion criteria apply to Stratum D:
• 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.

You may not qualify if…

• 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).

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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