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 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT06501768
Eligibility Criteria:
Inclusion Criteria:
* Presence of heart failure of ischemic or nonischemic etiology with LVEF \<40%.
* ATTR cardiomyopathy with any LVEF.
* Stable optimally tolerated dosages of HF therapies for 3 months with no change in medical management regimen for at least 1 month.
* NT-proBNP \>350 pg/mL.
Exclusion Criteria:
* Coronary intervention in the past 3 months.
* Pregnancy
* Cancer
* Patients on a vegan diet
* Patients taking supplements such as isoflavonoid or resveratrol.
* Ethanol abuse (men: \>4 drinks on any day or more than 14 drinks by week; women: \>3 drinks on any day or more than 7 drinks per week)
* Liver dysfunction (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3X ULN or total bilirubin greater than 1.5 times ULN)
* Renal dysfunction (eGFR less than 25 mL/min/1.73 m2)
* Uncontrolled diabetes (HgbA1c \>10%)
* Coagulopathies
* Cytopenia (leukocytopenia or hemoglobin \< 9 mg/dl or platelets \<100x103/mm3)
* Any patients who had been hospitalized in the past 3 months for reasons other than heart failure.
* NYHA Functional Class I or Functional Class IV symptoms.
* Acute bacterial or viral infectious disease, or acute exacerbation of a chronic infectious disease
* Known hypersensitivity to soy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06501768
Study Brief:
Protocol Section:
NCT06501768