Cancer Therapy Effects on the Heart

Heart Failure Clinical Trial

— CTEH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04262830
• Other study ID #: 181758
• Status: Recruiting
• Start date: September 30, 2019
• Est. completion date: September 30, 2029

Study information

• Verified date: April 2021
• Source: University of California, San Diego
• Contact: Hari Narayan, MD
• Phone: 8589665855
• Email: hnarayan[@]rchsd.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiotoxicity
• Heart Failure
• Pediatric Cancer

Intervention

Diagnostic Test:
• Cardiac magnetic resonance imaging (MRI)
Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics
• Echocardiography
Echocardiography, heart ultrasound, will be performed in conjunction with cardiac MRI.
• Electrocardiogram
Measuring conduction abnormalities

Locations

Country	Name	City	State
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Hari Narayan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF)	LVEF is an assessment of left ventricular global systolic function.	5 years