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Hematopoietic and Lymphoid System NeoplasmNCT05950399

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

A study testing Echocardiography, Electronic Health Record Review and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Echocardiography, Electronic Health Record Review and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
29 Jun 2015to 19 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Echocardiography, Electronic Health Record Review, Questionnaire Administration, Stress Echocardiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo resting echocardiography

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Stress EchocardiographyProcedure or surgery

    Also called Stress Echo

    Undergo stress echocardiography

Study groups in NCT05950399
Study groupRoleWhat they receive
Group I (resting and/or stress echocardiography)ExperimentalPatients 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.
Receives: Procedure: Echocardiography; Other: Electronic Health Record Review; Other: Questionnaire Administration; Procedure: Stress Echocardiography
Group II (stress echocardiography)Active comparatorParticipants undergo low intensity stress echocardiography over 25 minutes at baseline and may undergo a second one at least 24 hours later.
Receives: Procedure: Stress Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 12 months

  2. 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

    Measured: Baseline to 12 months

  3. 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.

    Measured: Baseline to 12 months

Secondary outcomes (2)

  1. Reductions in left ventricular ejection fraction (LVEF)

    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%.

    Measured: Up to 10 years

  2. Reductions in onset of clinical heart failure

    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.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2023
  2. Study start29 Jun 2015
  3. Primary completion19 Mar 2024
  4. Study completion19 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05950399
Sponsor's protocol ID
15-002855
Other IDs
NCI-2022-10806, 15-002855
Status last verified
Apr 2024
First submitted
10 Jul 2023
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Echocardiography, Electronic Health Record Review and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in cardiac function with low intensity exercise in cancer patients (time frame: Baseline to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05950399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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