Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity

Cardiotoxicity Clinical Trial

Official title:

Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798679
• Other study ID #: CV-2016-24434
• Status: Completed
• Start date: August 2016
• Est. completion date: September 1, 2022

Study information

• Verified date: October 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Stage I-III breast cancer or lymphoma with a >2 year life expectancy

• A treatment plan that includes anthracyclines and/or trastuzumab

• Age >45 years

• Able to hold breath for 10 seconds

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

• Refusal or inability to provide informed consent

• Known heart failure or LVEF <50%

• Heart rate over 100 bpm

• Renal dysfunction with GFR <30 mL/min/1.73m2

• Participants with pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices

• Symptomatic claustrophobia

• Plans to move within 24 months of enrollment

Related Conditions & MeSH terms

• Cardiotoxicity

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiotoxicity assessed clinically or by cardiac MRI		24 months