Stress Echocardiography to Identify Chemotherapy Induced Cardiotoxicity in Cancer Patients With Heart Failure Risk
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- 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,
- and mitral annular tissue Doppler (e', a'); Ig. Tricuspid tissue velocities and tricuspid annular plane systolic excursion (TAPSE).
SECONDARY OBJECTIVES:
- 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:
Ia. Occur before changes in resting strain or resting LVEF; Ib. Predict future reductions in LVEF (cardiotoxicity) or in the case of cardiac rehabilitation, prevention of LVEF decrease; Ic. Predict the development of clinical heart failure.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I (CASE): 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.
GROUP II (CONTROL): Participants undergo low intensity stress echocardiography over 25 minutes at baseline and may undergo a second one at least 24 hours later.
After completion of study intervention, patients in Group 1 are followed up at 2, 5, and 10 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Procedure: Echocardiography
Undergo resting echocardiography
Other Names:
Other: Electronic Health Record Review
Ancillary studies
Other: Questionnaire Administration
Ancillary studies
Procedure: Stress Echocardiography
Undergo stress echocardiography
Other Names:
|
| Active Comparator: 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. |
Procedure: Stress Echocardiography
Undergo stress echocardiography
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes in cardiac function with low intensity exercise in cancer patients [Baseline to 12 months]
Resting echocardiography will be perfromed immediatley before and after patient receives cancer therapeutic treatment. Up to five sessions of low intensity stress echcardiograms will be performed by during the course of teh study depending on twhere they are in the course of cancer therpy and/or cardiac rehabilitation program at study enrollment. Patients may opt to change from low intensity echcardiogram to resting ecochardiogram during teh course of the study. Data will be stored and analyzed using JMP. Nominal variables will be compared using Chi square analysis. Continuous variables will be compared using t-tests. Inter- and intra-observer variability will be assess using correlation coefficients.
- Changes in cardiac function with low intensity exercise in cancer patients after treatment with cancer therapeutics. [Baseline to 12 months]
Resting echocardiography will be perfromed immediatley before and after patient receives cancer therapeutic treatment. Up to five sessions of low intensity stress echcardiograms will be performed by during the course of teh study depending on twhere they are in the course of cancer therpy and/or cardiac rehabilitation program at study enrollment. Patients may opt to change from low intensity echcardiogram to resting ecochardiogram during teh course of the study. Data will be stored and analyzed using JMP. Nominal variables will be compared using Chi square analysis. Continuous variables will be compared using t-tests. Inter- and intra-observer variability will be assess using correlation coefficients.
- Changes in cardiac function with low intensity exercise in cancer patients after a periord of cardiac rehabilitation. [Baseline to 12 months]
Resting echocardiography will be perfromed immediatley before and after patient receives cancer therapeutic treatment. Up to five sessions of low intensity stress echcardiograms will be performed by during the course of teh study depending on twhere they are in the course of cancer therpy and/or cardiac rehabilitation program at study enrollment. Patients may opt to change from low intensity echcardiogram to resting ecochardiogram during teh course of the study. Data will be stored and analyzed using JMP. Nominal variables will be compared using Chi square analysis. Continuous variables will be compared using t-tests. Inter- and intra-observer variability will be assess using correlation coefficients.
Secondary Outcome Measures
- Reductions in left ventricular ejection fraction (LVEF) [Up to 10 years]
Data will be collected from chart reviews and patient surveys. Predictors of reductions in LVEF will be assessed using linear regression and multiple linear regression analyses. A p-value < 0.05 will define significance. Cancer Therapeutics-Related Cardiac Dysfunction will be defined as per recent guidelines as a drop in LVEF of > 10% to < 53%.
- Reductions in onset of clinical heart failure [Up to 10 years]
Data will be collected from chart reviews and patient surveys. Predictors of reductions in heart failure will be assessed using linear regression and multiple linear regression analyses. A p-value < 0.05 will define significance. Heart failure will be defined as a diagnosis made by one of the patients treating physicians.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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])
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Age >= 18 years at study enrollment
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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;
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Anti-HER2 targeted therapies (trastuzumab, pertuzumab)
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Vascular endothelial growth factor (VEGF) inhibitors (bevacizumab, sunitinib, sorafenib, pazopanib, axitinib, vandetanib)
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Immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab)
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Plan to undergo conditioning chemotherapy for bone marrow transplantation (autologous/allogeneic)
Exclusion Criteria:
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Coronary artery disease
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Significant (more than mild) valvular heart disease
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Pre-existing heart failure
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Pre-existing cardiomyopathy
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Musculoskeletal or neurologic abnormality prohibiting low intensity exercise on a stationary bicycle
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Severe pulmonary disease limiting ability to perform low intensity exercise on a stationary bicycle
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Hector R Villarraga, M.D., Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 15-002855
- NCI-2022-10806
- 15-002855