AiDing Diuresis wIth Tolvaptan (ADD-IT)

Exclusion Criteria

• •Positive urine pregnancy test for women of child bearing potential
• •Inability to provide written informed consent
• •Cardiac surgery within 60 days prior to study randomization
• •Acute Coronary Syndrome (ACS) or percutaneous coronary intervention within 30 days prior to study randomization
• •Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization
• •Planned electrophysiologic (EP) device implantation within 7 days following study randomization
• •Subjects who are on cardiac mechanical support
• •Co- morbid condition with an expected survival less than six months
• •History of a cerebrovascular accident within the last 30 days
• •Hemodynamically significant uncorrected primary cardiac valvular disease
• •Hypertrophic cardiomyopathy (obstructive or non-obstructive)
• •Uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy
• •History of primary significant liver disease or acute hepatic failure, defined as 3x upper limit of normal (ULN)
• •Chronic uncontrolled diabetes mellitus with Hemoglobin A1C \> 10%
• •Supine systolic arterial blood pressure \< 90 mmHg
• •Serum creatinine \> 3.5 mg/dL or undergoing dialysis
• •Hemoglobin \< 9 g/dL
• •History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazepril)
• •Inability to take oral medications
• •Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
• •Previous exposure to tolvaptan within 7 days prior to randomization
• •Subjects with refractory, end-stage, heart failure defined as subjects who are appropriate candidates for specialized treatment strategies, such as ventricular assist devices, continuous positive IV inotropic therapy, or hospice care
• •Ultrafiltration within 7 days prior to randomization or planned.
• •Active gout