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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT06233695
Eligibility Criteria:
Inclusion Criteria:
* The diagnosis of heart failure with reduced ejection fraction HFrEF (LVEF≤ 40%) and New York Heart Association (NYHA) class II-IV under optimized medical therapy who are presented to the outpatient clinic and started an aldosterone antagonist at the time of enrollment.
Exclusion Criteria:
* Pregnancy or breast-feeding.
* Serum creatinine \> 2.5 mg/dL (221 μmol/L) in males and \> 2 mg/dL (177 μmol/L) in women (or estimated glomerular filtration rate eGFR ≤ 30 mL/minute/1.73 m2).
* Hyperkalemia (serum potassium level \> 5 mEq/L).
* Renal transplant.
* Concomitant administration of strong CYP3A inhibitors.
* Concomitant administration of potassium supplements or potassium-sparing diuretics.
* Disorders of adrenal glands (Addison disease).
* Patients who used mineralocorticoid receptor antagonists in the last 2 weeks before enrollment.
* Patients with a history of mineralocorticoid receptor antagonists allergy or intolerance.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06233695
Study Brief:
Protocol Section:
NCT06233695