Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
PRIMARY OBJECTIVES:
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Evaluate cardiovascular reserve capacity, as measured by peak oxygen consumption (VO2peak), in hematopoietic cell transplantation (HCT) survivors.
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Observational (physical assessment) 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. |
Procedure: Bioelectric Impedance Analysis
Undergo bioelectric impedance analysis
Other Names:
Procedure: Biospecimen Collection
Undergo collection of blood samples
Procedure: Cardiopulmonary Exercise Testing
Undergo cardiopulmonary exercise test
Other Names:
Procedure: Echocardiography
Undergo echocardiogram
Procedure: Physical Performance Testing
Undergo physical function tests
Other Names:
Procedure: Pulmonary Function Test
Undergo pulmonary function test
Other Names:
Other: Questionnaire Administration
Ancillary studies
Procedure: Ultrasound
Undergo musculoskeletal ultrasound
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Outcome Measures
Primary Outcome Measures
- Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors [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.
- Determinants of VO2peak impairment in HCT survivors [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: cardiac (left ventricular function/ contractility [systolic, diastolic, cardiac output, strain], ventricular-arterial (VA) coupling, arterial elastance); pulmonary (obstructive, restrictive lung disease, diffusion capacity); musculoskeletal (body composition [% lean muscle mass], muscle quality, two minute step in place test, 30 second sit to stand test, timed up and go); and hematologic function, adjusting for potential confounding variables (e.g. age, sex) and time since HCT.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age at HCT >= 18 years
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Diagnosis of acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes
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Planning to undergo first autologous or allogeneic transplant
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Able to fluently read and write in English
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Able to understand and sign the study specific informed consent form (ICF)
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Physically able and willing to complete all study procedures
Exclusion Criteria:
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Unstable bone lesions per electronic medical record review and/or notification from patient's primary physician
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Unstable angina or history of acute myocardial Infarction (< 5 days of any planned study procedures)
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Recurrent syncope
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Acute myocarditis or pericarditis
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Symptomatic severe aortic stenosis
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Uncontrolled arrhythmia causing symptoms
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Pulmonary embolus < 3 month of study procedures
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Thrombosis of lower extremities
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Moderate or severe persistent asthma (National Asthma Education & Prevention)
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Room air desaturation at rest =< 85%
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Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
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Anemia (hemoglobin [Hgb] < 8 g/dL)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Saro H Armenian, City of Hope Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19424
- NCI-2020-06749
- 19424
- P30CA033572
- R01HL150069