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Early Detection of Iron Cardiomyopathy in Thalassemia (EDICT)

Dr. Paul Harmatz and Dr. Elliott Vichinsky at Children’s Hospital & Research Center at Oakland are participating in a study being done by Dr. John Wood, a cardiologist at Children’s Hospital Los Angeles (CHLA). The purpose of this four-year study is to measure the amount of iron in the heart and in the liver with T2 Star magnetic resonance imaging (MRI) and to see if the amount of heart and liver iron is related to how well the heart works (measured by other cardiac tests). From this study, patients will receive information about the amount of iron in their hearts as well as a complete evaluation of how well their hearts are functioning.

Who can participate?

    Inclusion Criteria
  • Patients who are chronically transfused
  • Patients who are over the age of 7 years
    Exclusion Criteria
  • Patients who are pregnant
  • Patients who are ineligible for an MRI due to incompatible metal implant(s), pacemaker, claustrophobia
  • Patients who are too ill to travel
  • Recipients of successful bone marrow transplants

What does the study involve?

  • Patients will be asked to stay overnight at a hotel close to CHLA, and during this 2-day stay, complete the following tests:
  • T2 Star/MRI (liver and heart)
  • Exercise stress test (treadmill and pulmonary function tests)
  • Echocardiogram and EKG
  • Holter monitor (18 hours)
  • Blood tests: one prior to and one following routine chelation (one
                tablespoon each time)
  • Urine collection (12 hours overnight)
  • Patients will be asked to repeat the CHLA visit(s) once per year for the next three years (four visits total) or once in the next three years (two visits total), depending on the T2 Star/MRI results (will be the same overnight stay at CHLA as described above).
  • Patients will be asked to visit the Pediatric Clinical Research Center (PCRC) at Children’s Hospital & Research Center at Oakland every six months for the length of the study. A chart review and interview will be performed related to updates on transfusions, chelation, and any cardiac tests done. These visits will be done at the same time as a regularly scheduled clinic or Day Hospital appointment.
  • CHLA visits need to be scheduled at least one month in advance and need to take place within one week following a routine transfusion.
  • Day 1 at CHLA must be on Monday through Thursday.
  • Visit starts between 11 and noon; discharge is at around noon the following day.
  • Children under the age of 18 years must travel with an adult guardian.
  • The study will reimburse up to $300 for travel.

For more information, please contact Ellen Butensky, PhD, PNP at Children's Hospital & Research Center at Oakland, 510-428-3885, ext. 7386 or ask your clinical care provider.


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