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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT04495712
Eligibility Criteria:
Inclusion Criteria:
-Patients were considered eligible for enrollment only if they had received
* an ICD therapy, either a shock or antitachycardia pacing (ATP),
* VT/VF in the previous 2 years or
* received an ICD for secondary prevention of sustained VT/VF in the previous 6 months.
Exclusion Criteria:
-Important exclusion criteria were
* an indication for spironolactone based on the RALES trial (EF of \<35% and -New York Heart Association (NYHA) class III or IV),
* unstable angina,
* primary hepatic failure,
* known intolerance to spironolactone,
* a serum creatinine concentration of \>2.5 mg/dL,
* a serum potassium concentration of \>5.0 mmol/L, and
* a life expectancy of \<2 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04495712
Study Brief:
Protocol Section:
NCT04495712