Evaluating Changes in Cardiac Function During Stress Echocardiography for the Identification of Chemotherapy Induced Cardiotoxicity in Cancer Patients at Risk of Developing Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Changes in cardiac function with low intensity exercise in cancer patients
研究概览
简要总结
This clinical trial evaluates changes in cardiac (heart) function during stress echocardiography to screen for chemically induced cardiotoxicity in cancer patients at a high risk for developing heart failure. Some chemotherapeutic agents to treat certain types of cancers can induce cardiac dysfunction and heart failure. Currently there is no validated means of predicting which patients will go on to develop cardiac toxicity and heart failure following treatment with chemotherapeutic agents. Stress echocardiography is a test that uses ultrasound imaging to show how well the heart muscle is working to pump blood to the body during low intensity exercise. Stress echocardiography prior to and during cancer treatment may help doctors find cancer therapeutic related cardiac dysfunction sooner when it may be easier to treat.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether changes in the following parameters of cardiac function at rest or with low intensity exercise occur following (1) treatment with cancer therapeutics or (2) cardiac rehabilitation:
Ia. 2-Dimensional (2D) and 3-dimensional (3D) left ventricular (LV) longitudinal strain and strain rate; Ib. Right ventricular (RV) longitudinal strain and strain rate; Ic. LV circumferential and radial strain and strain rate; Id. 2D and 3D wall motion; Ie. 2D and 3D volumetric left ventricular ejection fraction (LVEF); If. Mitral valve inflow velocities (E, A) and mitral annular tissue Doppler (e', a'); Ig. Tricuspid tissue velocities and tricuspid annular plane systolic excursion (TAPSE).
SECONDARY OBJECTIVES:
I. To determine whether changes after treatment with cancer therapeutics or a period of cardiac rehabilitation in any of the aforementioned parameters of cardiac function with low intensity exercise:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current or previous diagnosis of solid organ cancers (breast, non-small cell lung, rectal, renal, hepatic cancer, metastatic melanoma, sarcoma) or hematological disease (lymphoma, leukemia, multiple myeloma, monoclonal gammopathy of undetermined significance [MGUS])
- •Age >= 18 years at study enrollment
- •Plan to receive, or history of having received, chemotherapy (anthracycline, alkylating agent [cyclophosphamide, ifosfamide], and/or antimicrotubule agent [docetaxel, paclitaxel]) with or without specific targeted therapies;
- •Anti-HER2 targeted therapies (trastuzumab, pertuzumab)
- •Vascular endothelial growth factor (VEGF) inhibitors (bevacizumab, sunitinib, sorafenib, pazopanib, axitinib, vandetanib)
- •Immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab)
- •Plan to undergo conditioning chemotherapy for bone marrow transplantation (autologous/allogeneic)
排除标准
- •Coronary artery disease
- •Significant (more than mild) valvular heart disease
- •Pre-existing heart failure
- •Pre-existing cardiomyopathy
- •Musculoskeletal or neurologic abnormality prohibiting low intensity exercise on a stationary bicycle
- •Severe pulmonary disease limiting ability to perform low intensity exercise on a stationary bicycle
研究组 & 干预措施
Group I (resting and/or stress echocardiography)
Patients choose to undergo either a resting echocardiography performed before and after delivery of a cancer therapeutic agent and months 3, 6, 9 and 12 or up to 5 low intensity stress echocardiography over 25 minutes performed depending on where they are at in the course of their cancer therapy and/or cardiac rehabilitation program at baseline and/or months 3, 6, 9 and 12 after starting cancer therapy.
干预措施: Echocardiography (Procedure)
Group I (resting and/or stress echocardiography)
Patients choose to undergo either a resting echocardiography performed before and after delivery of a cancer therapeutic agent and months 3, 6, 9 and 12 or up to 5 low intensity stress echocardiography over 25 minutes performed depending on where they are at in the course of their cancer therapy and/or cardiac rehabilitation program at baseline and/or months 3, 6, 9 and 12 after starting cancer therapy.
干预措施: Electronic Health Record Review (Other)
Group I (resting and/or stress echocardiography)
Patients choose to undergo either a resting echocardiography performed before and after delivery of a cancer therapeutic agent and months 3, 6, 9 and 12 or up to 5 low intensity stress echocardiography over 25 minutes performed depending on where they are at in the course of their cancer therapy and/or cardiac rehabilitation program at baseline and/or months 3, 6, 9 and 12 after starting cancer therapy.
干预措施: Questionnaire Administration (Other)
Group I (resting and/or stress echocardiography)
Patients choose to undergo either a resting echocardiography performed before and after delivery of a cancer therapeutic agent and months 3, 6, 9 and 12 or up to 5 low intensity stress echocardiography over 25 minutes performed depending on where they are at in the course of their cancer therapy and/or cardiac rehabilitation program at baseline and/or months 3, 6, 9 and 12 after starting cancer therapy.
干预措施: Stress Echocardiography (Procedure)
Group II (stress echocardiography)
Participants undergo low intensity stress echocardiography over 25 minutes at baseline and may undergo a second one at least 24 hours later.
干预措施: Stress Echocardiography (Procedure)
结局指标
主要结局
Changes in cardiac function with low intensity exercise in cancer patients
时间窗: Baseline to 12 months
Resting echocardiography will be performed immediately before and after patient receives cancer therapeutic treatment. Up to five sessions of low intensity stress echocardiograms will be performed during the course of the study depending on where they are in the course of cancer therapy and/or cardiac rehabilitation program at study enrollment. Patients may opt to change from low intensity echocardiogram to resting echocardiogram during the course of the study.
Changes in cardiac function with low intensity exercise in cancer patients after a period of cardiac rehabilitation.
时间窗: Baseline to 12 months
Resting echocardiography will be performed immediately before and after patient receives cancer therapeutic treatment. Up to five sessions of low intensity stress echocardiograms will be performed by during the course of the study depending on where they are in the course of cancer therapy and/or cardiac rehabilitation program at study enrollment. Patients may opt to change from low intensity echocardiogram to resting echocardiogram during the course of the study.
Changes in cardiac function with low intensity exercise in cancer patients after treatment with cancer therapeutics.
时间窗: Baseline to 12 months
Resting echocardiography will be performed immediately before and after patient receives cancer therapeutic treatment. Up to five sessions of low intensity stress echocardiograms will be performed by during the course of the study depending on where they are in the course of cancer therapy and/or cardiac rehabilitation program at study enrollment. Patients may opt to change from low intensity echocardiogram to resting echocardiogram during the course of the study. D
次要结局
- Reductions in left ventricular ejection fraction (LVEF)(Up to 10 years)
- Reductions in onset of clinical heart failure(Up to 10 years)