Clinical Trials

Inclusion Criteria

• Male or non-pregnant/post-menopausal/sterile females
  • Post-menopausal is defined as the absence of menses for ≥ 1 year or serum follicle-stimulating hormone ≥ 20 IU/L
  • Sterilization in the female is defined as bilateral tubal occlusion for ≥ 6 months, bilateral oophorectomy, or complete hysterectomy
• Age 18-90
• In end-stage Heart Failure with LVAD support who are stable, in the healed stage, at least 3 months from the LVAD implant (Destination therapy only)
• Willing to provide informed consent
• All cardiac medications must be at stable doses 4 weeks prior to enrollment

Exclusion Criteria

• Known allergy or other adverse reactions to exogenous natriuretic peptides (CD-NP or its components, nesiritide, other natriuretic peptides, or related compounds)
• Pregnant, or breast-feeding
• Has received nesiritide within 7 days prior to entry into the study
• Has received any investigational drug or device within 30 days prior to entry into the study
• Clinically unstable (e.g. mean blood pressure < 70 mmHg, ongoing requirement for vasopressors, or mechanical ventilation)
• Recent hospitalization for decompensated HF or recent defibrillation for cardiac resuscitation within 30 days prior to randomization
• Has guarded prognosis and unlikely to derive meaningful benefit from CD-NP
• Presence of cardiac lesions or comorbidities that may contraindicate the use of natriuretic peptides, such as
  • Clinically significant cardiac valvular stenosis
  • Hypertrophic cardiomyopathy
  • Restrictive cardiomyopathy
  • Constrictive pericarditis
  • Primary pulmonary hypertension
  • Uncorrected congenital heart disease that contraindicates the use of vasodilators
• Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months
• Requirement of pressors for maintenance of blood pressure
• Intra-aortic blood pump use
• Severe aortic or mitral stenosis or significant LV outflow tract obstruction
• Clinically significant renal artery stenosis > 50%
• Baseline hemoglobin < 9.0 g/dl
• Serum sodium < 130 mEq/L, potassium < 3.6 mEq/L, or magnesium < 1.5 mEq/L
• Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at least 5 times the upper limit of normal or bilirubin at least 5 times the upper limit of normal
• Creatinine clearance (CrCl) < 30 ml.min-1.1.73m-2, as calculated by Cockcroft-Gault formula(67) and adjusted for body surface area within 3 months or requirement for dialysis
• Written history of alcohol or drug abuse within the past 6 months
• Inability to communicate effectively with study personnel
• BMI > 40