Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT02408432
Eligibility Criteria:
Inclusion Criteria:
* Patients with LVEF =\< 40% from treatment with anthracyclines for all malignancies at any dose at any time without evidence of other causes of cardiomyopathy
* Documented New York Heart Association (NYHA) class I, II and III
* Been treated with appropriate maximal medical therapy for heart failure
* Able to perform 6 minute walk test
* Patient or legally authorized representative able to sign informed consent
* Patients with persistent LV dysfunction 90 days after discontinuation of trastuzumab
Exclusion Criteria:
* Evidence of ischemic heart disease as determined by study cardiologist
* Significant valvular disease; (aortic stenosis \[AS\] with aortic valve area \[AVA\] \< 1.5 and severe aortic regurgitation \[AR\] and mitral regurgitation \[MR\])
* History of familial cardiomyopathy
* Recent documented myocarditis within 2 months of consent
* History of infiltrative cardiomyopathy or restrictive cardiomyopathy
* Epidermal growth factor receptor (eGFR) \< 50 by Mayo or Cockcroft formula
* Liver function tests \> 3 x upper limit of normal
* NYHA class IV heart failure
* Inotropic dependence
* Unstable or life-threatening arrhythmia
* Coagulopathy international normalized ratio (INR) \> 1.5
* Mechanical or bioprosthetic heart valve
* Cardiogenic shock
* Breast feeding and/or pregnant women
* Autoimmune disorders on current immunosuppressive therapy
* Active infection not responding to appropriate therapy as determined by study chair
* Trastuzumab treatment within the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02408432
Study Brief:
Protocol Section:
NCT02408432