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

Completed · Phase 2

Conditions studied: Heart Failure, Congestive

In brief

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.

Key facts

Study ID

NCT00159627

Run by

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

People needed

52

Starts

2004-08-01

Last updated by the study team

2008-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Stanford, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Sarasota, Florida, United States
• Study site — Baltimore, Maryland, United States
• Study site — Ayer, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Newark, New Jersey, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Tullahoma, Tennessee, United States

Full record on ClinicalTrials.gov

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