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

NCT00699712 | Completed Phase 2 DMC

• 1 other identifier: NIL-CDNP-CT003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

ADHF; AHF; HF

Outcome Measures

Primary Outcomes (1)

• Changes in cardiac output and wedge pressure

  8 hours

Secondary Outcomes (3)

• Changes in additional hemodynamic measures

  8 hours

• Diuresis and natriuresis during and after administration of study drug

  36 hour

• Safety of CD-NP

  30 Days

Study Arms (3)

A

EXPERIMENTAL

Open-label regimen of doses 1 and 2 of CDNP

Drug: CD-NP (Chimeric natriuretic peptide)

B

EXPERIMENTAL

Open-label regimen of doses 2 and 3 of CDNP

Drug: CD-NP (Chimeric natriuretic peptide)

C

EXPERIMENTAL

Open-label regimen of doses 3 and 4 of CDNP

Drug: CD-NP (Chimeric natriuretic peptide)

Interventions

CD-NP (Chimeric natriuretic peptide) DRUG

Infusion of CDNP at two of four doses

A; B; C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization for AHF
• In need of hemodynamic monitoring

You may not qualify if:

• 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

Sponsors & Collaborators

• Nile Therapeutics: lead
• Momentum Research, Inc.: collaborator

Study Sites (1)

Russian Academy of Medical Sciences

Moscow, Russia, 121552, Russia

Location

MeSH Terms

Interventions

cenderitide

Study Officials

• Hsiao Lieu, MD

  Nile Therapeutics Inc.

  STUDY DIRECTOR

• Gad Cotter, MD

  Momentum Research, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 18, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 25, 2009

Record last verified: 2009-03

Locations

RU (1)