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