Clinical trial NCT05950399: Stress Echocardiography to Identify Chemotherapy Induced Cardiotoxicity in Cancer Patients With Heart Failure Risk
Official title: Evaluating Changes in Cardiac Function During Stress Echocardiography for the Identification of Chemotherapy Induced Cardiotoxicity in Cancer Patients at Risk of Developing Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in cardiac function with low intensity exercise in cancer patients
timeFrame: Baseline to 12 months
measure: Changes in cardiac function with low intensity exercise in cancer patients after treatment with cancer therapeutics.
timeFrame: Baseline to 12 months
measure: Changes in cardiac function with low intensity exercise in cancer patients after a period of cardiac rehabilitation.
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Reductions in left ventricular ejection fraction (LVEF)
timeFrame: Up to 10 years
measure: Reductions in onset of clinical heart failure
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Hector R Villarraga, M.D.
role: PRINCIPAL_INVESTIGATOR
References: