Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure

Study Overview
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Brief Summary
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The primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients.

Official Title
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A Multi-Center, Single-Blind, Placebo-Controlled Phase 2 Study Assessing the Safety and Efficacy of Intravenous CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Drug: CD-NP


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Hospitalized for acute decompensated heart failure. Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening Renally compromised. Female patients must be post-menopausal or surgically sterile. Key Exclusion Criteria: Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3X the upper limit of normal at the institution's local laboratory Cardiogenic shock Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events Clinically significant aortic or mitral valve stenosis Temperature >38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment ADHF due to significant arrhythmias Severe renal failure defined as creatinine clearance < 30 mL/min Current or planned ultrafiltration, hemofiltration, or dialysis Significant pulmonary disease Major neurologic event, including cerebrovascular events in the prior 60 days. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns) Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Dose 1 of CD-NP | Drug: CD-NP<br>* Infusion of CD-NP at one of up to 6 doses or placebo<br>|
| Experimental: B<br>Dose 2 of CD-NP | Drug: CD-NP<br>* Infusion of CD-NP at one of up to 6 doses or placebo<br>|
| Experimental: C<br>Dose 3 of CD-NP | Drug: CD-NP<br>* Infusion of CD-NP at one of up to 6 doses or placebo<br>|
| Experimental: D<br>Dose 4 of CD-NP | Drug: CD-NP<br>* Infusion of CD-NP at one of up to 6 doses or placebo<br>|
| Experimental: E<br>Dose 5 of CD-NP | Drug: CD-NP<br>* Infusion of CD-NP at one of up to 6 doses or placebo<br>|
| Experimental: F<br>Dose 6 of CD-NP | Drug: CD-NP<br>* Infusion of CD-NP at one of up to 6 doses or placebo<br>|
| Placebo Comparator: G<br>Placebo | Drug: CD-NP<br>* Infusion of CD-NP at one of up to 6 doses or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion. |  | Up to 72 hours | 

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