Cancer Therapy Effects on the Heart (CTEH)
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|ClinicalTrials.gov Identifier: NCT04262830|
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : April 30, 2021
|Condition or disease||Intervention/treatment|
|Cardiotoxicity Pediatric Cancer Heart Failure||Diagnostic Test: Cardiac magnetic resonance imaging (MRI) Diagnostic Test: Echocardiography Diagnostic Test: Electrocardiogram|
Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.
Cardiac remodeling, function, and tissue characteristics will be examined using cardiac MRI data in combination with standard cardiac assessments (by echocardiography, electrocardiograms, and cardiac MRI) to assess the cardiotoxic effects of cancer therapy. Analyses will be performed in a cohort of adolescents and young adults with a history of childhood cancer.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Cancer Therapy Effects on the Heart: Identification of Early Markers of Cardiac Disease Progression After Cardiotoxic Childhood Cancer Therapy Using Cardiac Magnetic Resonance Imaging|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2029|
All Study Participants
This is an observational study where all study participants are within a single group.
Diagnostic Test: Cardiac magnetic resonance imaging (MRI)
Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics
Diagnostic Test: Echocardiography
Echocardiography, heart ultrasound, will be performed in conjunction with cardiac MRI.
Diagnostic Test: Electrocardiogram
Measuring conduction abnormalities
- Left ventricular ejection fraction (LVEF) [ Time Frame: 5 years ]LVEF is an assessment of left ventricular global systolic function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262830
|Contact: Hari Narayan, MDfirstname.lastname@example.org|
|Contact: James Kolar||8585761700 ext email@example.com|
|United States, California|
|Rady Children's Hospital||Recruiting|
|San Diego, California, United States, 92123|
|Contact: Hari Narayan, MD 858-966-5855 firstname.lastname@example.org|
|Contact: James Kolar 8585761700 ext 223457 email@example.com|
|Principal Investigator: Hari Narayan, MD|
|Sub-Investigator: Dennis Kuo, MD|
|Sub-Investigator: Mark Abcede, MBA|
|Sub-Investigator: James Kolar, BS|
|Principal Investigator:||Hari Narayan, MD||University of California San Diego, Rady Children's Hospital|