Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure

NCT ID: NCT04262830

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2030-09-30

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.

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 in combination with other research assessments 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.

Conditions

Cardiotoxicity; Pediatric Cancer; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Study Participants

This is an observational study where all study participants are within a single group.

Participants will have testing performed at baseline and again at follow-up >= 3 years after the initial assessment.

Cardiac magnetic resonance imaging (MRI)

Intervention Type: DIAGNOSTIC_TEST

Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics

Accelerometer physical activity monitoring

Intervention Type: OTHER

Measurement of physical activity using hip-worn accelerometer.

Interventions

Cardiac magnetic resonance imaging (MRI)

Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics

Intervention Type: DIAGNOSTIC_TEST

Accelerometer physical activity monitoring

Measurement of physical activity using hip-worn accelerometer.

Intervention Type: OTHER

Eligibility 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).
• Pregnancy (at the time of enrollment).

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hari Narayan

OTHER

Sponsor Role: lead

Responsible Party

Hari Narayan

Assoc Physician Dipl

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hari Narayan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California San Diego, Rady Children's Hospital

Locations

Rady Children's Hospital

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hari Narayan, MD

Role: CONTACT

hnarayan@rchsd.org

8589665855 / 8589331718

Cesar Vasquez

Role: CONTACT

cvasquez2@rchsd.org

8589331718

Facility Contacts

Hari Narayan, MD

Role: primary

hnarayan@rchsd.org

858-966-5855

Maria Teresa Acuero, MAS

Role: backup

macuero@rchsd.org

8585761700 ext. 227139

Other Identifiers

181758

Identifier Type: -

Identifier Source: org_study_id