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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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 to IV loop diuretics in subjects with acute heart failure syndrome and renal impairment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovaCardia, Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Diuretics; Purinergic P1 Receptor Antagonists; Rolofylline

Criteria

Inclusion Criteria:

1. History of heart failure of at least 14 days duration for which diuretic therapy has been prescribed

2. Hospitalized for acute heart failure syndrome requiring IV diuretic therapy.

3. Impaired renal function

Exclusion Criteria:

1. Acute contrast induced nephropathy

2. Ongoing or planned IV therapy for heart failure with positive inotropic agents, vasopressors, vasodilators, or mechanical support with the exception of IV nitrates

3. BNP <500pg/mL or NT-pro-BNP <2000 pg/mL

4. Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis

5. Severe pulmonary disease

6. Significant stenotic valvular disease

7. Heart transplant recipient or admitted for cardiac transplantation

8. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening

9. Heart failure due to significant arrhythmias

10. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.

11. Known hepatic impairment

12. Non-cardiac pulmonary edema, including suspected sepsis

13. Allergy to soybean oil or eggs

14. History of seizure

15. Stroke within 2 years

16. History of or current brain tumor of any etiology

17. Brain surgery within 2 years

18. Encephalitis/meningitis within 2 years

19. History of penetrating head trauma

20. Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years

21. History of, or at risk for, alcohol withdrawal seizures

22. Advanced Alzheimer's disease

23. Advanced multiple sclerosis

24. Hgb <8 g/dL, Hct <25%, or the need for a blood transfusion

25. Previous exposure to KW-3902