Expired Study
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Tustin, California 92780


Purpose:

Planned enrollment is approximately twelve subjects with stable chronic heart failure. Enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose increasing, subcutaneous (SQ) infusions of open-label cenderitide via the Insulet Drug Delivery System. Planned infusion rates of cenderitide will be administered to subjects continuously during four, 48-hour infusion periods.


Criteria:

Key Inclusion Criteria: - Male or female, ≥ 18 years of age - Body Mass Index (BMI) of 18-40 kg/m2, inclusive - Current or historical New York Heart Association (NYHA) functional class ≥ II - At least one of the following: documented systolic heart failure with an ejection fraction (EF) ≤ 40% and/or a historical measurement of plasma BNP ≥ 150 pg/mL (or NT-proBNP ≥ 600 pg/mL) - Systolic blood pressure 100-160 mmHg - Stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to Screening Key Exclusion Criteria: - Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds - Current clinical diagnosis of acute decompensated heart failure (ADHF) - Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to Screening. - Symptomatic postural hypotension - Evidence of uncorrected volume or sodium ≤ 130 mmol/L or other condition that would predispose the patient to adverse events - Clinically significant aortic or mitral valve stenosis - Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns) - Severe renal failure defined as creatinine clearance < 45 mL/min as estimated by either the Cockcroft-Gault or the MDRD equations - Significant pulmonary disease (e.g., history of oral daily steroid dependency, history of Carbon Dioxide (CO2) retention or need for intubation for acute exacerbation, or currently receiving IV steroids) - Known hepatic impairment as indicated by any of the following: A) total bilirubin > 3 mg/dL; B) albumin < 2.8 mg/dL, with other signs or symptoms of hepatic dysfunction; C) increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction


NCT ID:

NCT02359227


Primary Contact:

Principal Investigator
Joel Neutel, MD
Orange County Research Center


Backup Contact:

N/A


Location Contact:

Tustin, California 92780
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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