Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure (CATCH-HF)
CATCH-HF: Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure
Study Overview
Status
Conditions
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
Enrollment (Estimated)
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
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California
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San Diego, California, United States, 92123
- Recruiting
- Rady Children's Hospital
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Contact:
- Hari Narayan, MD
- Phone Number: 858-966-5855
- Email: hnarayan@rchsd.org
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Contact:
- Maria Teresa Acuero, MAS
- Phone Number: 227139 8585761700
- Email: macuero@rchsd.org
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Contact:
- Hari Narayan, MD
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Contact:
- Dennis Kuo, MD
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Contact:
- Mark Abcede, MBA
-
Contact:
- Maria Teresa Acuero, MAS
-
Contact:
- Cesar Vasquez, BS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
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. |
Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics
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)
Time Frame: 3 - 5 years
|
LVEF is an assessment of left ventricular global systolic function.
|
3 - 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hari Narayan, MD, University of California San Diego, Rady Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181758
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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