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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT03695120
Eligibility Criteria:
Inclusion Criteria:
Patients are eligible for enrollment if within the previous 24 hours they were treated with acute decompensated heart failure or diagnosed on the basis of the investigator's clinical diagnosis of heart failure, which needs to be supported by at least 2 the following criteria:
* Elevated concentration of B-type natriuretic peptide (BNP) or N-terminal pro-BNP. (Elevated BNP" defined as \>300 for sinus rhythm, \>500 for patients will atrial fibrillation and elevated pro BNP defined as \>1000 for sinus rhythm, \>1600 for atrial fibrillation.)
* Pulmonary edema on physical examination.
* Radiologic pulmonary congestion or edema.
* History of Chronic Heart Failure. Anticipated need for IV loop diuretics for at least 48 hours
* Willingness to provide informed consent
Exclusion Criteria:
* Previously diagnosed end-stage renal disease; Serum Potassium \>5.5 mmol/L
* Cardiogenic Shock within 48 hours, ST-segment elevation myocardial infarction, ongoing ischemia.
* Need for renal replacement therapy through dialysis or ultrafiltration
* Myocardial infarction within 30 days of screening.
* Patients with systolic blood pressure of less than 90 mm Hg.
* Patients requiring Intravenous Vasodilators or inotropic agents (other than Digoxin) for heart failure
* BNP less than 250 ng/ml and/or proBNP less than 1000 mg/ml
* Pregnant women, prisoners, and institutionalized individuals
* Severe stenotic valvular disease
* Complex congenital heart disease
* Need for mechanical hemodynamic support
* Sepsis
* Terminal illness (other than HF) with expected survival of less than one year
* Previous adverse reaction to the study drugs
* Use of IV iodinated radiocontrast material in last 72 hours or planned during hospitalization
* Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
* Inability to comply with planned study procedures
* Primary admission diagnosis other than acute heart failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03695120
Study Brief:
Protocol Section:
NCT03695120