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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT00206232
Eligibility Criteria:
Inclusion Criteria:
* Women who are 18 years of age or older.
* Women with clinical heart failure for \> 2 months.
* Women with left ventricular ejection fraction \> 50% within 2 months of screening.
* Women with New York Heart Association class II or III heart failure symptoms.
* Brain Natriuretic Peptide \> 62 pg/ml within 2 months of screening.
* Patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
* Blood Pressure no more than 150/95.
* Patient able to walk more than 50 meters at the time of enrollment.
* Signed informed consent.
Exclusion Criteria:
* Current treatment with spironolactone.
* Severe hepatic impairment.
* Creatinine \> 2.5 mg/dl
* Potassium \> 5.0 mEq/L
* Intolerance to spironolactone in the past.
* Significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.
* Unstable angina or myocardial infarction within the past 4 weeks.
* Severe peripheral vascular disease or other physical conditions that would limit the walking distance.
* Pregnant or lactating females.
* Participation in any other drug trial within 30 days prior to randomization.
* Inability to provide informed consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00206232
Study Brief:
Protocol Section:
NCT00206232