Recruiting

Cardiotoxicity Assessment

Sponsor:

Hari Narayan

Code:

NCT04262830

Conditions

Cardiotoxicity

Pediatric Cancer

Heart Failure

Eligibility Criteria

Sex: All

Age: 13 - 39

Healthy Volunteers: Not accepted

Interventions

Cardiac magnetic resonance imaging (MRI)

Accelerometer physical activity monitoring

Study Details

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.

Conditions

Cardiotoxicity

Pediatric Cancer

Heart Failure

Study ID

NCT04262830

Start date

Sep 30, 2019

Status verified date

Jan, 2025

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 39

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Cardiac magnetic resonance imaging (MRI)

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

Accelerometer physical activity monitoring

Measurement of physical activity using hip-worn accelerometer.

Primary outcome measure

  • Left ventricular ejection fraction (LVEF) [ Time Frame: 3 - 5 years ]

Central Contacts and Locations

Central contacts

Hari Narayan, MD

8589665855 / 8589331718hnarayan@rchsd.org

Cesar Vasquez

8589331718cvasquez2@rchsd.org

Locations

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Hari Narayan, MD

858-966-5855hnarayan@rchsd.org

Maria Teresa Acuero, MAS

8585761700macuero@rchsd.org

Principal Investigator:

Hari Narayan, MD

More Information

Sponsor

Hari Narayan

Last update posted

Jan 28, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hari Narayan on 2025-01-28.