Clinical trial NCT04262830: Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure
Official title: CATCH-HF: Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiotoxicity
Pediatric Cancer
Heart Failure
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 150
Sex: ALL
Minimum age (years): 13
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long-term childhood cancer survivors treated with anthracyline therapy.

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.

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).

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 3 - 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
affiliation: University of California San Diego, Rady Children's Hospital
name: Hari Narayan, MD
role: PRINCIPAL_INVESTIGATOR
References: