Congestive Heart Failure, Renal Insufficiency
Conditions
Keywords
renal insufficiency, diuretic, congestive heart failure, acute decompensated heart failure
Brief summary
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
Interventions
DRUGtonapofylline
IV
DRUGPlacebo
IV
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous diagnosis of heart failure. * Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
Exclusion criteria
* History of an allergic reaction to any xanthine-containing substance. * History of seizure * History of stroke * Myocardial infarction * Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy. * Serious systemic infection * Major surgical procedures within 30 days * Acute coronary syndrome * Cardiogenic shock * Baseline body weight \>150 kg * Participation in any other investigational study of drugs or devices within 30 days prior to Screening * Nursing mothers, pregnant women, or women planning on becoming pregnant during the study * Presence of any clinically significant condition that might interfere with optimal safe participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency. | 0-60 days |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Czechia, Finland, France, Germany, India, Israel, Italy, Netherlands, Poland, Romania, Russia, Sweden, United States
Outcome results
None listed