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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT00577135
Eligibility Criteria:
Inclusion Criteria:
* Prior clinical diagnosis of heart failure that was treated with daily oral loop diuretics for at least 1 month
* Current diagnosis of heart failure, as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
* Daily oral dose of furosemide between 80 mg and 240 mg (or equivalent)
* Identified within 24 hours of hospital admission
* Current treatment plan includes IV loop diuretics for at least 48 hours
Exclusion Criteria:
* Brain natriuretic peptide (BNP) less than 250 mg/mL or N-terminal prohormone brain natriuretic peptide (NT-proBNP) less than 1000 mg/mL
* Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation
* Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for heart failure
* Substantial diuretic response to pre-randomization diuretic dosing such that higher doses of diuretics would be medically inadvisable
* Systolic blood pressure less than 90 mm Hg
* Serum creatinine level greater than 3.0 mg/dL at baseline or currently undergoing renal replacement therapy
* Hemodynamically significant arrhythmias
* Acute coronary syndrome within 4 weeks prior to study entry
* Active myocarditis
* Hypertrophic obstructive cardiomyopathy
* Severe stenotic valvular disease
* Restrictive or constrictive cardiomyopathy
* Complex congenital heart disease
* Constrictive pericarditis
* Non-cardiac pulmonary edema
* Clinical evidence of digoxin toxicity
* Need for mechanical hemodynamic support
* Sepsis
* Terminal illness (other than heart failure) with expected survival time of less than 1 year
* History of adverse reaction to the study drugs
* Use of IV iodinated radiocontrast material within 72 hours prior to study entry or planned during hospitalization
* Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
* Inability to comply with planned study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00577135
Study Brief:
Protocol Section:
NCT00577135