Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
Phase 2
Completed
- Conditions
- Acute Decompensated Heart Failure
- Interventions
- Registration Number
- NCT00699712
- Lead Sponsor
- Nile Therapeutics
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A CD-NP (Chimeric natriuretic peptide) Open-label regimen of doses 1 and 2 of CDNP B CD-NP (Chimeric natriuretic peptide) Open-label regimen of doses 2 and 3 of CDNP C CD-NP (Chimeric natriuretic peptide) Open-label regimen of doses 3 and 4 of CDNP
- Primary Outcome Measures
Name Time Method Changes in cardiac output and wedge pressure 8 hours
- Secondary Outcome Measures
Name Time Method Safety of CD-NP 30 Days Changes in additional hemodynamic measures 8 hours Diuresis and natriuresis during and after administration of study drug 36 hour
Trial Locations
- Locations (1)
Russian Academy of Medical Sciences
🇷🇺Moscow, Russia, Russian Federation