Status:
COMPLETED
PROTECT-1: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function
Lead Sponsor:
NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is being conducted to examine whether KW-3902IV will result in greater improvement in signs and symptoms of heart failure, with less treatment failure than standard therapy, when it is added...
Detailed Description
Loop diuretics are generally first line therapy in patients hospitalized with acute heart failure syndrome (AHFS). Their use far exceeds that of vasoactive agents. Tubuloglomerular feedback (TGF) is t...
Eligibility Criteria
Inclusion
- History of heart failure of at least 14 days duration for which diuretic therapy has been prescribed
- Hospitalized for acute heart failure syndrome requiring IV diuretic therapy.
- Impaired renal function
Exclusion
- Acute contrast induced nephropathy
- Ongoing or planned IV therapy for heart failure with positive inotropic agents, vasopressors, vasodilators, or mechanical support with the exception of IV nitrates
- BNP \<500pg/mL or NT-pro-BNP \<2000 pg/mL
- Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis
- Severe pulmonary disease
- Significant stenotic valvular disease
- Heart transplant recipient or admitted for cardiac transplantation
- Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening
- Heart failure due to significant arrhythmias
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.
- Known hepatic impairment
- Non-cardiac pulmonary edema, including suspected sepsis
- Allergy to soybean oil or eggs
- History of seizure
- Stroke within 2 years
- History of or current brain tumor of any etiology
- Brain surgery within 2 years
- Encephalitis/meningitis within 2 years
- History of penetrating head trauma
- Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years
- History of, or at risk for, alcohol withdrawal seizures
- Advanced Alzheimer's disease
- Advanced multiple sclerosis
- Hgb \<8 g/dL, Hct \<25%, or the need for a blood transfusion
- Previous exposure to KW-3902
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
932 Patients enrolled
Trial Details
Trial ID
NCT00328692
Start Date
August 1 2006
End Date
July 1 2009
Last Update
October 9 2009
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