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

NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase

Completed

Phase 2

Conditions

Heart Failure, Congestive

Treatments

Drug: KW-3902IV

Study type

Interventional

Funder types

Industry

Identifiers

NCT00159627

CKI-202

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.