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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00839007

Enrollment

Registered

2009-02-09

Start date

2009-06-30

Completion date

2010-07-31

Last updated

2010-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Decompensated Heart Failure

Keywords

ADHF, AHF, HF

Brief summary

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.

Interventions

DRUGCD-NP

Infusion of CD-NP at one of up to 6 doses or placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: 1. Hospitalized for acute decompensated heart failure. 2. Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening 3. Renally compromised. 4. Female patients must be post-menopausal or surgically sterile. Key

Exclusion criteria

1. Acute or suspected acute myocardial infarction (AMI) or troponin levels \> 3X the upper limit of normal at the institution's local laboratory 2. Cardiogenic shock 3. Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events 4. Clinically significant aortic or mitral valve stenosis 5. Temperature \>38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment 6. ADHF due to significant arrhythmias 7. Severe renal failure defined as creatinine clearance \< 30 mL/min 8. Current or planned ultrafiltration, hemofiltration, or dialysis 9. Significant pulmonary disease 10. Major neurologic event, including cerebrovascular events in the prior 60 days. 11. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns) 12. Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds

Design outcomes

Primary

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

Countries

Germany, Israel, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026