Early Identification of Chemotherapy Induced Cardiac Toxicity

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-002855
    Sponsor Protocol Number: 15-002855

About this study

The purpose of this study is to determine whether changes in the following parameters of cardiac function with low intensity exercise occur following anthracycline therapy:

  • 2D and 3D left ventricular (LV) longitudinal strain and strain rate
  • Right ventricular (RV) longitudinal strain and strain rate
  • LV circumferential and radial strain and strain rate
  • 2D and 3D wall motion
  • 2D and 3D volumetric LVEF
  • Mitral valve inflow velocities (E, A) and mitral annular tissue Doppler (e’, a’)
  • Tricuspid tissue velocities and TAPSE

The study will also determine whether changes after chemotherapy in any of the aforementioned parameters of cardiac function with low intensity exercise:

  • Occur before changes in resting strain or resting LVEF
  • Predict future reductions in LVEF (cardiotoxicity)
  • Predict the development of clinical heart failure

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Current or previous diagnosis of breast cancer or lymphoma
  • Age ≥18 years at study enrollment
  • Plan to receive, or history of having received, chemotherapy which includes an anthracycline.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hector Villarraga, M.D.

Open for enrollment

Contact information:

Carolyn Larsen M.D.

Larsen.Carolyn@mayo.edu

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CLS-20306791

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