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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Drug: CD-NP (Chimeric natriuretic peptide)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Open-label regimen of doses 1 and 2 of CDNP | Drug: CD-NP (Chimeric natriuretic peptide)<br>* Infusion of CDNP at two of four doses<br>|
| Experimental: B<br>Open-label regimen of doses 2 and 3 of CDNP | Drug: CD-NP (Chimeric natriuretic peptide)<br>* Infusion of CDNP at two of four doses<br>|
| Experimental: C<br>Open-label regimen of doses 3 and 4 of CDNP | Drug: CD-NP (Chimeric natriuretic peptide)<br>* Infusion of CDNP at two of four doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac output and wedge pressure |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHF, AHF, HF