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

Heart Failure, Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159627
• Other study ID #: CKI-202
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: January 28, 2008
• Start date: August 2004

Study information

• Verified date: January 2008
• Source: NovaCardia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• KW-3902IV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NovaCardia, Inc.	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urine volume from baseline