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

NCT05950399 | Completed DMC

• 2 other identifiers: 15-002855NCI-2022-10806
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• Changes in cardiac function with low intensity exercise in cancer patients

  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.

  Baseline to 12 months

• Changes in cardiac function with low intensity exercise in cancer patients after treatment with cancer therapeutics.

  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

  Baseline to 12 months

• Changes in cardiac function with low intensity exercise in cancer patients after a period of cardiac rehabilitation.

  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.

  Baseline to 12 months

Secondary Outcomes (2)

• Reductions in left ventricular ejection fraction (LVEF)

  Up to 10 years

• Reductions in onset of clinical heart failure

  Up to 10 years

Study Arms (2)

Group I (resting and/or stress echocardiography)

EXPERIMENTAL

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; Other: Electronic Health Record Review; Other: Questionnaire Administration; Procedure: Stress Echocardiography

Group II (stress echocardiography)

ACTIVE COMPARATOR

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

Interventions

Echocardiography PROCEDURE

Undergo resting echocardiography

Also known as: EC

Group I (resting and/or stress echocardiography)

Electronic Health Record Review OTHER

Ancillary studies

Group I (resting and/or stress echocardiography)

Questionnaire Administration OTHER

Ancillary studies

Group I (resting and/or stress echocardiography)

Stress Echocardiography PROCEDURE

Undergo stress echocardiography

Also known as: Stress Echo

Group I (resting and/or stress echocardiography); Group II (stress echocardiography)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Hector R Villarraga, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: June 29, 2015
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

US (1)