Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).

A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of the Effects of KW-3902 on Diuresis in Patients With Congestive Heart Failure (CHF) Refractory to High Dose Diuretic Therapy

The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with volume overload due to CHF who are refractory to high dose diuretic therapy.

Inclusion Criteria:

• History of CHF for greater than 3 months,
• Receiving oral/IV diuretic therapy
• Hospitalized for therapy for HF and edema that has not responded to diuretic therapy.
• Signs and symptoms of ongoing volume overload

Exclusion Criteria:

• Myocardial infarction in past 14 days
• Clinical evidence of acute coronary syndrome causing worsening of HF,
• Pregnant or breast-feeding,
• Severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
• Automated implanted cardiac defibrillator (AICD) or synchronization device implanted within the preceding 7 days,
• Require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
• Deterioration due to an acute or superimposed condition requiring therapy other than diuretics
• Symptomatic ventricular tachycardia,
• Severe concomitant primary hepatic disease,
• Severe pulmonary disease,
• Any other concomitant life-threatening disease,
• CVA in the preceding 6 months,
• Hypotension,
• Participated in another clinical trial within 30 days,
• Acute contrast nephropathy,
• Admitted for heart transplant surgery or have had a heart transplant.