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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovaCardia, Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Diuretics; Rolofylline

Criteria

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.