Early Identification of Chemotherapy Induced Cardiac Toxicity
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
Site IRB
- Rochester, Minnesota: 15-002855
NCT ID: NCT05950399
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 (1) treatment with cancer therapeutics or (2) cardiac rehabilitation:
- 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 treatment with cancer therapeutics or a period of cardiac rehabilitation 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) or in the case of cardiac rehabilitation, prevention of LVEF decrease/
- 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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Current or previous diagnosis of solid organ cancers (breast, non-small cell lung, rectal, renal, hepatic cancer, metastatic melonoma) or hematological cancer (lymphoma).
- Age ≥ 18 years old 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.
- 1. anti-HER2 targeted therapies (Trastuzumab, Pertuzumab).
- 2. VEGF inhibitors (Bevacizumab, sunitinib, sorafenib, pazopanib, axitinib, vandetanib).
- 3. Immune checkpoint inhibitors (Ipilimumab, Nivolumab, Pembrolizumab).
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Hector Villarraga, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available