Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure (CATCH-HF)

CATCH-HF: Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cardiotoxicity; Pediatric Cancer
• Intervention / Treatment: Diagnostic test: Cardiac magnetic resonance imaging (MRI); Other: Accelerometer physical activity monitoring

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Hari Narayan, MD; Phone Number: 8589665855 / 8589331718; Email: hnarayan@rchsd.org
• Study Contact Backup: Name: Cesar Vasquez; Phone Number: 8589331718; Email: cvasquez2@rchsd.org

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Hospital
      • Contact: Hari Narayan, MD; Phone Number: 858-966-5855; Email: hnarayan@rchsd.org
      • Contact: Maria Teresa Acuero, MAS; Phone Number: 227139 8585761700; Email: macuero@rchsd.org
      • Contact: Hari Narayan, MD
      • Contact: Dennis Kuo, MD
      • Contact: Mark Abcede, MBA
      • Contact: Maria Teresa Acuero, MAS
      • Contact: Cesar Vasquez, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Long-term childhood cancer survivors treated with anthracyline therapy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics; Other: Accelerometer physical activity monitoring; Measurement of physical activity using hip-worn accelerometer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular ejection fraction (LVEF)	LVEF is an assessment of left ventricular global systolic function.	3 - 5 years

Collaborators and Investigators

• Sponsor: Hari Narayan
• Investigators: Principal Investigator: Hari Narayan, MD, University of California San Diego, Rady Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Heart Diseases; Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Heart Failure; Cardiotoxicity
• Other Study ID Numbers: 181758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No