CardiotoxicityCATCH-HFNCT04262830
Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure
An observational study of Cardiotoxicity and Pediatric Cancer, run by Hari Narayan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 39 years
- Conditions the study is for
- Cardiotoxicity, Pediatric Cancer, Heart Failure
- What is being tested?
- Cardiac magnetic resonance imaging (MRI) and Accelerometer physical activity monitoring
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 30 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Long-term childhood cancer survivors treated with anthracyline therapy.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Hari Narayan, MD, 858-966-5855, hnarayan@rchsd.org
Maria Teresa Acuero, MAS, 8585761700 ext. 227139, macuero@rchsd.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiotoxicity, Pediatric Cancer, Heart Failure
- Being tested
- Cardiac magnetic resonance imaging (MRI), Accelerometer physical activity monitoring
- Medical subject headings
- Cardiotoxicity, Neoplasms, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance imaging (MRI)Diagnostic test
Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics
Accelerometer physical activity monitoringOther
Measurement of physical activity using hip-worn accelerometer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cardiac magnetic resonance imaging (MRI); Other: Accelerometer physical activity monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
LVEF is an assessment of left ventricular global systolic function.
Measured: 3 - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start30 Sep 2019
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hari Narayan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hari Narayan, University of California, San Diego
- Investigators
- Hari Narayan, MD, Principal investigator, University of California San Diego, Rady Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262830
- Sponsor's protocol ID
- 181758
- Acronym
- CATCH-HF
- Status last verified
- Jan 2025
- First submitted
- 4 Nov 2019
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Narayan HK, Chen S, Wong FL, Young N, Qi A, Davis C, Hegde S, Gloude N, Leger KJ, Getz KD, Contijoch F, Ness K, Ky B, Kuo D, Hartman SJ, Armenian SH. The Relationship Between Physical Activity and Left Ventricular Remodeling in Childhood Cancer Survivors Treated With Anthracyclines: A Cross-Sectional Study. Pediatr Blood Cancer. 2026 Jul 25:e70523. doi: 10.1002/1545-5017.70523. Online ahead of print.
PubMed 42499264
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CATCH-HF: Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure
- ClinicalTrials.gov ID
- NCT04262830
- Acronym / sponsor ID
- CATCH-HF / 181758
- Conditions
- Cardiotoxicity, Pediatric Cancer, Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hari NarayanUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | – | Diagnostic Test: Cardiac magnetic resonance imaging (MRI), Other: Accelerometer physical activity monitoringThis 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. |
Who may qualify
- Ages
- 13 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Long-term childhood cancer survivors treated with anthracyline therapy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac magnetic resonance imaging (MRI)Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics | Diagnostic test | All Study Participants |
| Accelerometer physical activity monitoringMeasurement of physical activity using hip-worn accelerometer. | Other | All Study Participants |
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: 3 - 5 years
LVEF is an assessment of left ventricular global systolic function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Derived from this study: PubMed 42499264Narayan HK, Chen S, Wong FL, Young N, Qi A, Davis C, Hegde S, Gloude N, Leger KJ, Getz KD, Contijoch F, Ness K, Ky B, Kuo D, Hartman SJ, Armenian SH. The Relationship Between Physical Activity and Left Ventricular Remodeling in Childhood Cancer Survivors Treated With Anthracyclines: A Cross-Sectional Study. Pediatr Blood Cancer. 2026 Jul 25:e70523. doi: 10.1002/1545-5017.70523. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hari Narayan, MD principal investigator
University of California San Diego, Rady Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Pediatric Cancer, run by Hari Narayan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hari Narayan, MD (8589665855 / 8589331718, hnarayan@rchsd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) (time frame: 3 - 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.