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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
Sponsor:
Information provided by (Responsible Party):
Hari Narayan, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiotoxicity Pediatric Cancer Heart Failure Diagnostic Test: Cardiac magnetic resonance imaging (MRI) Diagnostic Test: Echocardiography Diagnostic Test: Electrocardiogram

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Left ventricular ejection fraction (LVEF) [ Time Frame: 5 years ]
    LVEF is an assessment of left ventricular global systolic function.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Long-term childhood cancer survivors treated with anthracyline therapy.
Criteria

Inclusion Criteria:

  • English and Spanish speaking male and female subjects, ages 13-39 years old
  • Diagnosis of cancer at age <22 years
  • Previously treated with anthracyline therapy for cancer, with diagnosis at least two years prior.

Exclusion Criteria:

  • Patients who have a contraindication to cardiac MRI, including the presence of non-MRI compatible metallic implants.
  • Medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would preclude the subject from undergoing the cardiac MRI without anesthesia.
  • Patients with a history of congenital heart disease (more significant than a history of patent foramen ovale or patent ductus arteriosus).
  • Patients with orthodontic braces or metallic implants in the thorax or abdomen/lumbar spine, even if MRI-compatible, will be excluded as these may cause artifacts and limit image quality.
  • Pregnancy.

Information from the National Library of Medicine

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


Contacts
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Contact: Hari Narayan, MD 8589665855 hnarayan@rchsd.org
Contact: James Kolar 8585761700 ext 223457 jkolar@rchsd.org

Locations
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United States, California
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Hari Narayan, MD    858-966-5855    hnarayan@rchsd.org   
Contact: James Kolar    8585761700 ext 223457    jkolar@rchsd.org   
Principal Investigator: Hari Narayan, MD         
Sub-Investigator: Dennis Kuo, MD         
Sub-Investigator: Mark Abcede, MBA         
Sub-Investigator: James Kolar, BS         
Sponsors and Collaborators
Hari Narayan
Investigators
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Principal Investigator: Hari Narayan, MD University of California San Diego, Rady Children's Hospital
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Responsible Party: Hari Narayan, Assoc Physician Dipl, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04262830    
Other Study ID Numbers: 181758
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries