Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)

Acute Decompensated Heart Failure Clinical Trial

— PreCONDITION  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699712
• Other study ID #: NIL-CDNP-CT003
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2008
• Last updated: March 23, 2009
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Nile Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Drug:
• CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses

Locations

Country	Name	City	State
Russian Federation	Russian Academy of Medical Sciences	Moscow	Russia

Sponsors (2)

Lead Sponsor	Collaborator
Nile Therapeutics	Momentum Research, Inc.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cardiac output and wedge pressure		8 hours	No
Secondary	Changes in additional hemodynamic measures		8 hours	No
Secondary	Diuresis and natriuresis during and after administration of study drug		36 hour	No
Secondary	Safety of CD-NP		30 Days	Yes

External Links

•   Sponsor