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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT02543294
Eligibility Criteria:
Inclusion Criteria:
1. Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment.
2. Prior diagnosis of CILVD with recovered LVEF (i.e. improved to \> 50%) for at least 6 months with recommended HF medications (ACE-I or ARB and/or B-blocker).
3. Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinician's documentation
4. Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy.
5. Age 18 - 80 years. HF clinical guidelines is supported by evidenced-based data from clinical trials which includes individuals up to 80 years of age.
6. Residence within the United States.
7. Ability to read and write English, because the MD Anderson Symptom Inventory -Heart Failure (MDASI-HF) instrument (Fadol et al., 2008) has been validated in English only.
Exclusion Criteria:
1. Participants will be excluded if they have a recurrence that requires anti-cancer treatment.
2. Have a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis.
3. Exhibiting HF symptoms (e.g. shortness of breath, edema).
4. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02543294
Study Brief:
Protocol Section:
NCT02543294