Cardiotoxicity Assessment Through Comprehensive Heart Ima... | NCT04262830

Studies
Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure

NCT04262830

Sponsor

Hari Narayan

Status

Recruiting

Last Update Posted

Jan 28, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Cardiotoxicity
Pediatric Cancer
Heart Failure

Interventions

Cardiac magnetic resonance imaging (MRI)
Accelerometer physical activity monitoring

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2019Actual

Primary Completion Date

Sep 30, 2028Estimated

Completion Date

Sep 30, 2030Estimated

First Submitted Date

Nov 4, 2019

First Submission Date that Met QC Criteria

Feb 7, 2020

First Posted Date

Feb 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2025

Last Update Posted Date

Jan 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cardiac magnetic resonance imaging (MRI)	Diagnostic Test	Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

39 Years

Standard Ages

ChildAdult

Study Population

Long-term childhood cancer survivors treated with anthracyline therapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hari Narayan, MD	Contact	8589665855 / 8589331718		hnarayan@rchsd.org
Cesar Vasquez	Contact	8589331718		cvasquez2@rchsd.org

Overall Officials

Name	Affiliation	Role
Hari Narayan, MD	University of California San Diego, Rady Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rady Children's Hospital	Recruiting	San Diego	California	92123	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D066126	Cardiotoxicity
D009369	Neoplasms
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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