Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency

Inclusion Criteria:

18 years of age or older
Diagnosis of heart failure requiring hospitalization >1 and ≤12 months prior to screening
NYHA Class III or IV at the time of screening
Renal insufficiency as defined by eGFR ≥20 and ≤70 mL/min/1.73 m2
Negative pregnancy test

Exclusion Criteria:

History of an allergic reaction to any xanthine-containing compound.
History of seizure
History of stroke
Serious systemic infection
Sustained systolic blood pressure >170 or <90 mmHg
Myocardial infarction within 30 days of Day 1
Hemodynamically destabilizing arrhythmia within 30 days of Day 1
Uncorrected hemodynamically significant primary valvular disease
Known obstructive or restrictive cardiomyopathy
Cardiac surgery within 60 days prior to Day 1
Likely to undergo cardiac transplantation, device implantation, or other cardiac surgery within next three months
Evidence of malignancy within 6 months prior to Day 1.
Participation in any other investigational study of drugs or devices within 30 days prior to Day 1.
Receiving aminophylline, theophylline, pentoxifylline, dyphylline or adenosine
Presence of any clinically significant condition that might interfere with optimal safe participation in this study