| June 10, 2008 |
| March 23, 2009 |
| June 2008 |
| December 2008 (final data collection date for primary outcome measure) |
| Changes in cardiac output and wedge pressure [ Time Frame: 8 hours ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00699712 on ClinicalTrials.gov Archive Site |
- Changes in additional hemodynamic measures [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
- Diuresis and natriuresis during and after administration of study drug [ Time Frame: 36 hour ] [ Designated as safety issue: No ]
- Safety of CD-NP [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| 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) |
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 |
| |
| Phase II |
| Interventional |
| Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Acute Decompensated Heart Failure |
| Drug: CD-NP (Chimeric natriuretic peptide) |
- Experimental: Open-label regimen of doses 1 and 2 of CDNP
- Experimental: Open-label regimen of doses 2 and 3 of CDNP
- Experimental: Open-label regimen of doses 3 and 4 of CDNP
|
| |
| |
| Completed |
| 30 |
| December 2008 |
| December 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Russian Federation |
| |
| NCT00699712 |
| Hsiao Lieu, MD / Vice President, Clinical Research, Nile Therapeutics |
| NIL-CDNP-CT003 |
| Nile Therapeutics |
| Momentum Research, Inc. |
| Study Director: |
Hsiao Lieu, MD |
Nile Therapeutics Inc. |
|
| Study Director: |
Gad Cotter, MD |
Momentum Research, Inc. |
|
|
| Nile Therapeutics |
| March 2009 |