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:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT01614860
Eligibility Criteria:
Inclusion criteria:
* Male or female ≥ 18 years of age
* AHF is the primary working diagnosis for ER management and treatment Have received or will receive IV diuretic therapy
* Enrolled within 12 hours of initial diuretic dose order
Exclusion criteria:
* Serum Cr ≥ 2.5mg/dL (males) or 2.0mg/dL (females), or eGFR \< 20 ml/min/1.73m2
* Serum potassium ≥ 5.5 mEq/L
* Transplant recipients of any kind
* Fever \> 101.0
* Severe lung disease (required home O2 or daily oral steroids)
* Acute coronary syndrome within last 30 days
* Major surgery within last 30 days
* Known hypertrophic obstructive cardiomyopathy, pericardial constriction, or hemodynamically significant valvular disease
* Life expectancy less than 12 months for any reason
* Current treatment for any malignancy of any kind
* Cardiogenic shock and/or requiring IV inotropic therapy
* Pregnant or recently pregnant within last 90 days
* Known intolerance to aldosterone antagonist
* Inability to give appropriate written consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01614860
Study Brief:
Protocol Section:
NCT01614860