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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04367051
Eligibility Criteria:
Inclusion Criteria:
* Willing and capable of providing informed consent and agrees to follow the study protocol and schedule of clinical follow-up
* Age between 19 and 80 years old
* Prior diagnosis of heart failure with reduced left ventricular ejection fraction (LV EF ≤ 35%) and on medical therapy including spironolactone combined with angiotensin-converting enzyme or angiotensin receptor blocker or antiotensin receptior neprilysin blocker, beta-blocker.
* LV EF ≥ 50% documented with echocardiography performed within a month
* Documented result of BNP or NT-proBNP level within a month
Exclusion Criteria:
* Dyspnea ≥ New York Heart Association (NYHA) functional class III
* Patients who need to discontinue spironolactone owing to prior adverse event
* Primary valvular heart disease with at least moderate degree
* Estimated glomerular filtration rate less than 30 mL/min per 1.73 m2
* Uncontrolled hypertension defined as blood pressure more than 140/90 mmHg
* Presence of other clinical reason to continue spironolactone such as myocardial infarction, primary aldosteronism, and liver cirrhosis
* Hyperkalemia defined as serum potassium level less than 3.5 mmol per liter
* Pregnant and/or lactating women
* Life expectancy less than a year
* Patients who are not suitable to enrollment by investigator's discretion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT04367051
Study Brief:
Protocol Section:
NCT04367051