City of Hope Medical Center
Duarte, California, 91010, United States
NCT Number: NCT04537871
This study evaluates how well the heart, lungs, and muscles are working individually, and how these systems are working together in transplant survivors. Information collected in this study may help doctors to understand why hematopoietic stem cell transplant survivors are at higher risk for developing cardiovascular disease.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Duarte, California, 91010, United States
PRIMARY OBJECTIVES:
I. Evaluate cardiovascular reserve capacity, as measured by peak oxygen consumption (VO2peak), in hematopoietic cell transplantation (HCT) survivors.
II. Define the determinants of VO2peak impairment in HCT survivors.
OUTLINE:
Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo bioelectric impedance analysis
Other names: BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis, Bioimpedance Analysis
Undergo collection of blood samples
Undergo cardiopulmonary exercise test
Other names: CPET, CPX
Undergo echocardiogram
Undergo physical function tests
Other names: Physical Fitness Testing, Physical Function Testing
Undergo pulmonary function test
Other names: lung function test, PFT, Pulmonary Function Testing, Pulmonary Function Tests
Ancillary studies
Undergo musculoskeletal ultrasound
Time frame: Up to 24 months post-hematopoietic cell transplantation (HCT)
We will measure initial VO2peak in patients prior to HCT and its post-HCT trajectory over time; compare VO2peak in HCT survivors at baseline (pre-HCT), 6m, 1Y, and 2Y post-HCT to established age- and sex-normative data; and define the association between VO2peak and self-reported health-related quality of life (HRQOL) at baseline/over time.
Time frame: Up to 24 months post-hematopoietic cell transplantation (HCT)
We will use Generalized Estimating Equation(GEE) and generalized linear models to examine the correlation between VO2peak and measures of:
City of Hope Medical Center
Other
Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05972577
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Columbus, Ohio, United States
View Trial DetailsNCT03622788
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Houston, Texas, United States
View Trial DetailsNCT04060277
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
Duarte, California, United States
View Trial DetailsNCT04666025
Accelerated Phase CML, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
Duarte, California, United States
View Trial Details