Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at HCT >= 18 years
- •Diagnosis of acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes
- •Planning to undergo first autologous or allogeneic transplant
- •Able to fluently read and write in English
- •Able to understand and sign the study specific informed consent form (ICF)
- •Physically able and willing to complete all study procedures
排除标准
- •Unstable bone lesions per electronic medical record review and/or notification from patient's primary physician
- •Unstable angina or history of acute myocardial Infarction (< 5 days of any planned study procedures)
- •Recurrent syncope
- •Acute myocarditis or pericarditis
- •Symptomatic severe aortic stenosis
- •Uncontrolled arrhythmia causing symptoms
- •Pulmonary embolus < 3 month of study procedures
- •Thrombosis of lower extremities
- •Moderate or severe persistent asthma (National Asthma Education & Prevention)
- •Room air desaturation at rest =< 85%
- •Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
- •Anemia (hemoglobin [Hgb] < 8 g/dL)
研究组 & 干预措施
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.
干预措施: Bioelectric Impedance Analysis (Procedure)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Cardiopulmonary Exercise Testing (Procedure)
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.
干预措施: Echocardiography (Procedure)
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.
干预措施: Physical Performance Testing (Procedure)
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.
干预措施: Pulmonary Function Test (Procedure)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Ultrasound (Procedure)
结局指标
主要结局
Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors
时间窗: 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
时间窗: 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: 1. cardiac (left ventricular function/ contractility \[systolic, diastolic, cardiac output, strain\], ventricular-arterial (VA) coupling, arterial elastance); 2. pulmonary (obstructive, restrictive lung disease, diffusion capacity); 3. 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 4. hematologic function, adjusting for potential confounding variables (e.g. age, sex) and time since HCT.
次要结局
未报告次要终点