PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function
Heart Failure, Congestive
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring heart failure, diuretic, renal impairment, renal function
Eligibility Criteria
Inclusion Criteria: History of heart failure of at least 14 days duration for which diuretic therapy has been prescribed Hospitalized for acute heart failure syndrome requiring IV diuretic therapy. Impaired renal function Exclusion Criteria: Acute contrast induced nephropathy Ongoing or planned IV therapy for heart failure with positive inotropic agents, vasopressors, vasodilators, or mechanical support with the exception of IV nitrates BNP <500 pg/mL or NT-pro-BNP <2000 pg/mL Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis Severe pulmonary disease Significant stenotic valvular disease Heart transplant recipient or admitted for cardiac transplantation Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening Heart failure due to significant arrhythmias Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. Known hepatic impairment Non-cardiac pulmonary edema, including suspected sepsis Allergy to soybean oil or eggs History of seizure Stroke within 2 years History of or current brain tumor of any etiology Brain surgery within 2 years Encephalitis/meningitis within 2 years History of penetrating head trauma Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years History of, or at risk for, alcohol withdrawal seizures Advanced Alzheimer's disease Advanced multiple sclerosis Hgb <8 g/dL, Hct <25%, or the need for a blood transfusion Previous exposure to KW-3902
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
1
2