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Cardiomyopathy Following Stem Cell Transplantation

NCT00352209 · Status: COMPLETED · Type: OBSERVATIONAL

Last updated 2017-07-02

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-02
Completion
2007-05-16

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00352209 on ClinicalTrials.gov