CardiomyopathyNCT00352209
Cardiomyopathy Following Stem Cell Transplantation
An observational study of Cardiomyopathy, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiomyopathy
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- 2 May 2006to 16 May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
Bethesda, Maryland, 20892
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Retrospective Review of Cardiomyopathy Patient Cases Post Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read more
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.
Read the 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.
- Conditions
- Cardiomyopathy
- Keywords
- Cyclophosphamide, Preparative Regimens, Risk Factors, Chart Review, Incidence
- Medical subject headings
- Cardiomyopathies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study start2 May 2006
- Study completion16 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352209
- Sponsor's protocol ID
- 060158
- Other IDs
- 06-CC-0158
- Status last verified
- 16 May 2007
- First submitted
- 13 Jul 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 3533179
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Cardiomyopathy Patient Cases Post Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00352209
- Acronym / sponsor ID
- 060158
- Conditions
- Cardiomyopathy
- Keywords
- Cyclophosphamide, Preparative Regimens, Risk Factors, Chart Review, Incidence
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 2 May 2006
- Study completion
- 16 May 2007
- First posted
- 14 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 3533179Goldberg MA, Antin JH, Guinan EC, Rappeport JM. Cyclophosphamide cardiotoxicity: an analysis of dosing as a risk factor. Blood. 1986 Nov;68(5):1114-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00352209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.