Acute Decompensated Heart Failure
Conditions
Keywords
ADHF, AHF, HF
Brief summary
To 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
Interventions
DRUGCD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
Sponsors
Momentum Research, Inc.
Nile Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cardiac output and wedge pressure | 8 hours |
Secondary
| Measure | Time frame |
|---|---|
| Changes in additional hemodynamic measures | 8 hours |
| Diuresis and natriuresis during and after administration of study drug | 36 hour |
| Safety of CD-NP | 30 Days |
Countries
Russia
Outcome results
None listed