Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF) (PreCONDITION)
This study has been completed.
Sponsor:
Nile Therapeutics
Collaborator:
Momentum Research, Inc.
Information provided by:
Nile Therapeutics
ClinicalTrials.gov Identifier:
NCT00699712
First received: June 10, 2008
Last updated: March 23, 2009
Last verified: March 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Decompensated Heart Failure |
Drug: CD-NP (Chimeric natriuretic peptide) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Nile Therapeutics:
Primary Outcome Measures:
- Changes in cardiac output and wedge pressure [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Open-label regimen of doses 1 and 2 of CDNP
|
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
|
|
Experimental: B
Open-label regimen of doses 2 and 3 of CDNP
|
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
|
|
Experimental: C
Open-label regimen of doses 3 and 4 of CDNP
|
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699712
Locations
| Russian Federation | |
| Russian Academy of Medical Sciences | |
| Moscow, Russia, Russian Federation, 121552 | |
Sponsors and Collaborators
Nile Therapeutics
Momentum Research, Inc.
Investigators
| Study Director: | Hsiao Lieu, MD | Nile Therapeutics Inc. |
| Study Director: | Gad Cotter, MD | Momentum Research, Inc. |
More Information
Additional Information:
Sponsor 
No publications provided
| Responsible Party: | Hsiao Lieu, MD / Vice President, Clinical Research, Nile Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00699712 History of Changes |
| Other Study ID Numbers: | NIL-CDNP-CT003 |
| Study First Received: | June 10, 2008 |
| Last Updated: | March 23, 2009 |
| Health Authority: | Israel: Ministry of Health Russia: Pharmacological Committee, Ministry of Health |
Keywords provided by Nile Therapeutics:
|
ADHF AHF HF |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013