Trial Information

Retrospective Review of Cardiomyopathy Patient Cases Post Allogeneic Hematopoietic Stem Cell Transplantation

Cardiac complications in patients who have undergone allogeneic hematopoietic stem cell
transplantation (HSCT) have been well documented. Most commonly patients present with
congestive heart failure and/or pericarditis after receiving high-dose cyclophosphamide,
total body irradiation (TBI) or other intensive conditioning / preparative regimens prior to
the allogeneic transplant. The majority of the data in the medical literature suggests that
the rate of serious cardiac events appears to be relatively low at approximately 5% or less.
Recently, there appears to have been a cluster of patient cases (approximately 15) of
significant cardiomyopathy in patients who have received an allogeneic HSCT at the NIH
Clinical Center over the past year. These cases have been consulted on by the Cardiology
consult service and have included both NCI and NHLBI protocol patients. This cluster of
cases has prompted concern that the incidence of cardiac toxicity recently seen at the NIH
Clinical Center is not consistent with the reported incidence of significant cardiac
toxicity in the medical literature.

The proposed retrospective chart review is intended to further define the incidence of
cardiac toxicity, primarily focusing on cardiomyopathy. The project is an initial step to
consolidate the data from both the NCI and NHLBI transplant programs and clarify the
documented cardiac toxicities, the incidence, and the demographics of the patient
populations. We also plan to document the presence or absence of a variety of known and
suspected risk factors for cardiotoxicity. This analysis will only be preliminary but will
potentially lead to more formal prospective studies on cardiotoxicity related to allogeneic
HSCT.