Stress Echocardiography to Identify Chemotherapy Induced Cardiotoxicity in Cancer Patients With Heart Failure Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-29

Study Completion Date

2024-03-19

Brief Summary

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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.

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Detailed Description

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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:

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.

Conditions

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Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Echocardiography

Intervention Type PROCEDURE

Undergo resting echocardiography

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Stress Echocardiography

Intervention Type PROCEDURE

Undergo stress echocardiography

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.

Group Type ACTIVE_COMPARATOR

Stress Echocardiography

Intervention Type PROCEDURE

Undergo stress echocardiography

Interventions

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Echocardiography

Undergo resting echocardiography

Intervention Type PROCEDURE

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Stress Echocardiography

Undergo stress echocardiography

Intervention Type PROCEDURE

Other Intervention Names

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EC Stress Echo

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes