Cardiomyopathy Following Stem Cell Transplantation

NCT00352209 | Completed

• 2 other identifiers: 06015806-CC-0158
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Cardiomyopathy

Keywords

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* ELIGIBILITY CRITERIA: Patients who have undergone an allogeneic HSCT on either an NHLBI or NCI protocol since 1999 will be the patient population for this chart review. Patients with documented serious cardiac events will be identified from NHLBI cardiology consult records, NCI and NHLBI research data bases, and the data base of the echocardiogram service.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (2)

National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Goldberg MA, Antin JH, Guinan EC, Rappeport JM. Cyclophosphamide cardiotoxicity: an analysis of dosing as a risk factor. Blood. 1986 Nov;68(5):1114-8.

  PMID: 3533179 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 14, 2006
• Study Start: May 2, 2006
• Study Completion: May 16, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-05-16

Locations

US (2)