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

Phase 2

Completed

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00159627
• Lead Sponsor: NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-28
• Last Update Posted: 2008-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in urine volume from baseline