A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study to Assess The Effects of Intravenous BG9928 on Body Weight in Subjects with Acute Decompensated Heart Failure and Renal Insufficiency - 160HF301, Trident I

Conditions: Acute Decompensated Heart Failure and Renal Insufficiency
MedDRA version: 9.1Level: LLTClassification code 10064653Term: Acute decompensated heart failure

Registration Number: EUCTR2007-007395-42-IT

Lead Sponsor: BIOGEN IDEC LTD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

Inclusion Criteria

Unless otherwise specified, to be eligible to participate in this study, candidates must have met the following eligibility criteria at the time of randomization: 1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]). 2. Aged 18 years or older at the time of informed consent. 3. Must have previous diagnosis of systolic or diastolic heart failure. 4. Must have ADHF, requiring hospitalization, with clinical evidence for volume overload as demonstrated by at least 2 of the following features: a. Dyspnea or orthopnea b. Rales c. Peripheral edema d. Increased jugular venous pressure e. Chest X-ray consistent with CHF f. Plasma BNP ≥150 pg/mL or NT pro-BNP ≥450 pg/mL 5. Subject requires hospitalization for treatment with IV diuretics for the current episode of ADHF and meets both of the following: a. has received at least 40 mg of furosemide (or equivalent) for the treatment of the current episode of ADHF within 24 hours prior to randomization unless a rationale for a lower dose is provided by the enrolling Investigator, and b. is randomized within 24 hours of first dose of IV diuretic administered for this episode of ADHF. 6. Renal insufficiency at the time of screening as defined by eGFR ≥20 and ≤70 mL/min/1.73 m2 (determined at the site according to the formula in Appendix 1). 7. Must be able to stand on a standardized scale for weight measurement. 8. All female subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 7 days after their last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of an allergic reaction to any xanthine-containing substance. 2. History of seizure within the past 10 years or use of any medications for the suppression of seizures within the past 5 years. 3. History of stroke, transient ischemic attack, or head injury with loss of consciousness within the past 6 months. 4. History consistent with illicit use of drugs or alcohol abuse within 6 months prior to Screening. 5. Myocardial infarction (MI) or hemodynamically destabilizing arrhythmia (e.g., ventricular fibrillation or hemodynamically significant ventricular or supraventricular tachycardia) within 30 days of Screening. 6. Cardiac surgery or pacemaker placement within 60 days prior to Screening. 7. Uncorrected hemodynamically significant primary valvular disease or known obstructive or restrictive cardiomyopathy. 8. Serious systemic infection (e.g., septicemia) or major surgical procedures within the 30 days prior to Day 1. 9. Evidence of malignancy within 6 months prior to screening. Subjects with a history of stable prostate cancer, basal cell carcinomas, or fewer than 3 squamous cell carcinomas of the skin are eligible. 10. Receiving aminophylline-, theophylline-, or adenosine-containing substances. 11. Current hospitalization initiated by transfer from another acute care inpatient setting. 12. Acute coronary syndrome (ACS) within 48 hours prior to screening evidenced by significant changes in cardiac biomarkers and electrocardiogram (ECG) changes consistent with ischemia. 13. Cardiogenic shock as indicated by the need for IV inotropes or vasopressors or a systolic blood pressure <80 mmHg. 14. Respiratory failure at Screening or impending respiratory failure likely requiring invasive ventilatory support within 8 hours of screening, in the judgment of the enrolling Investigator. 15. Anticipated need for <48 hours hospitalization from Screening (as judged by the enrolling Investigator). 16. Anticipated need for cardiac catheterization during the current hospitalization (as judged at Screening by the enrolling Investigator). 17. Likely to undergo cardiac transplantation, left ventricular assist device (LVAD) or other device implantation, or other cardiac surgery within next 3 months. 18. Anticipated need for use of ultrafiltration or renal replacement therapy (e.g.,hemodialysis or peritoneal dialysis). 19. Baseline body weight >150 kg. 20. Fever, with body temperature >38 oC, within the 48 hours prior to first dose. 21. Screening laboratory findings as follows: a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal b. Total bilirubin >2.0 mg/dL c. Hematocrit <28% or an anticipated need for a blood transfusion 22. Participation in any other investigational study of drugs or devices within 30 days prior to Screening. 23. Nursing mothers, pregnant women, or women planning on becoming pregnant during the study. 24. Presence of any clinically significant (as determined by the Investigator)endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and/or other major disease that might interfere with optimal safe participation in this study.