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

Nile Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: CD-NP (Chimeric natriuretic peptide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00699712

NIL-CDNP-CT003

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

A

Experimental group

Description:

Open-label regimen of doses 1 and 2 of CDNP

Treatment:

Drug: CD-NP (Chimeric natriuretic peptide)

B

Experimental group

Description:

Open-label regimen of doses 2 and 3 of CDNP

Treatment:

Drug: CD-NP (Chimeric natriuretic peptide)

C

Experimental group

Description:

Open-label regimen of doses 3 and 4 of CDNP

Treatment:

Drug: CD-NP (Chimeric natriuretic peptide)