Cardiomyopathy Following Stem Cell Transplantation
Condition: Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Observational

Summary: 
      This study will examine the incidence of cardiac complications, particularly cardiomyopathy,
      in patients who have undergone allogeneic (donor) stem cell transplantation at NIH. Cardiac
      complications in these patients are well documented. Most commonly, patients develop
      congestive heart failure or pericarditis after receiving high-dose cyclophosphamide,
      radiation, or other intensive chemotherapy regimens prior to the transplant.

      Most data in the medical literature suggest that the rate of serious cardiac complications is
      relatively low, at about 5 percent or less. Recently, a cluster of cases of significant
      cardiomyopathy in stem cell transplant patients at the NIH Clinical Center has prompted
      concern that the incidence of these complications is higher than that reported in the medical
      literature.

      This study will further define the incidence of cardiac problems, primarily focusing on
      cardiomyopathy, with the following objectives:

        -  To define the incidence of cardiomyopathy in allogeneic stem cell transplant patients
           enrolled in National Cancer Institute (NCI) and National Heart, Lung, and Blood (NHLBI)
           protocols at the NIH Clinical Center

        -  To document the presence or absence of various known or suspected risk factors for
           cardiomyopathy in the documented cases.

      The study consists of a chart review of patients who have had an allogeneic stem cell
      transplant on either an NHLBI or NCI protocol since 1999.

      This project is a first step in clarifying the cardiac complications following stem cell
      transplantation, their incidence, and characteristics of the patient populations. It will
      look at patient demographics, the characteristics of the cardiac complication, and known or
      suspected risk factors.
    

Detailed description: 
      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.
    

Keywords: Cyclophosphamide; Preparative Regimens; Risk Factors; Chart Review; Incidence