Title
Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
Multi-Center, Open Label, Dose Escalating, Sequential Group Study to Assess the Hemodynamic Effects, Safety and Tolerability of CD-NP in Patients With Stabilized Acute Heart Failure (AHF)
Phase
Phase 2Lead Sponsor
Nile TherapeuticsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Acute Decompensated Heart FailureIntervention/Treatment
chimeric natriuretic peptide ...Study Participants
30To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac output and wedge pressure in patients with stabilized acute heart failure
Infusion of CDNP at two of four doses
Open-label regimen of doses 1 and 2 of CDNP
Open-label regimen of doses 2 and 3 of CDNP
Open-label regimen of doses 3 and 4 of CDNP
Key Inclusion Criteria: Hospitalization for AHF In need of hemodynamic monitoring Key Exclusion Criteria: Administration of intravenous radiographic contrast agent within 7 days prior to screening or planned IV contrast media administration in the 4 days after screening or acute contrast-induced nephropathy at the time of screening Current or planned treatment with any IV therapies, including diuretics, vasodilators (including nesiritide), vasopressin antagonists, positive inotropic agents and vasopressors, or mechanical support Current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of screening Significant pulmonary disease Known valvular heart disease Any organ transplant recipient or patient currently listed for transplant or admitted for any transplantation. Major surgery within 30 days of screening Other major disability or disease with expected survival less than 6 months. Major neurologic event, including cerebrovascular events, in the 60 days prior to screening Clinical diagnosis of acute coronary syndrome within 45 days of screening Troponin T ≥ 3 times the upper limit of normal at screening Significant arrhythmias Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy Liver function abnormality Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days prior to screening