Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure

NCT04262830 | Recruiting

• 1 other identifier: 181758
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction (LVEF)

  LVEF is an assessment of left ventricular global systolic function.

  3 - 5 years

Study Arms (1)

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.

Diagnostic Test: Cardiac magnetic resonance imaging (MRI); Other: Accelerometer physical activity monitoring

Interventions

Cardiac magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

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

All Study Participants

Accelerometer physical activity monitoring OTHER

Measurement of physical activity using hip-worn accelerometer.

All Study Participants

Eligibility Criteria

• Age: 13 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Long-term childhood cancer survivors treated with anthracyline therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hari Narayan: lead

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Neoplasms; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Hari Narayan, MD

  University of California San Diego, Rady Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hari Narayan, MD

CONTACT

8589665855 / 8589331718; hnarayan@rchsd.org

Cesar Vasquez

CONTACT

8589331718; cvasquez2@rchsd.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Physician Dipl

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: February 10, 2020
• Study Start: September 30, 2019
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2030
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (1)