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

NCT ID: NCT00699712

Last Updated: 2009-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-12-31

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

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Open-label regimen of doses 1 and 2 of CDNP

Group Type: EXPERIMENTAL

CD-NP (Chimeric natriuretic peptide)

Intervention Type: DRUG

Infusion of CDNP at two of four doses

B

Open-label regimen of doses 2 and 3 of CDNP

Group Type: EXPERIMENTAL

CD-NP (Chimeric natriuretic peptide)

Intervention Type: DRUG

Infusion of CDNP at two of four doses

C

Open-label regimen of doses 3 and 4 of CDNP

Group Type: EXPERIMENTAL

CD-NP (Chimeric natriuretic peptide)

Intervention Type: DRUG

Infusion of CDNP at two of four doses

Interventions

CD-NP (Chimeric natriuretic peptide)

Infusion of CDNP at two of four doses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Hospitalization for AHF
• In need of hemodynamic monitoring

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Momentum Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Nile Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Nile Therapeutics

Principal Investigators

Hsiao Lieu, MD

Role: STUDY_DIRECTOR

Nile Therapeutics Inc.

Gad Cotter, MD

Role: STUDY_DIRECTOR

Momentum Research, Inc.

Locations

Russian Academy of Medical Sciences

Moscow, Russia, Russia

Countries

Russia

Other Identifiers

NIL-CDNP-CT003

Identifier Type: -

Identifier Source: org_study_id