Status:
COMPLETED
CD-NP in Subjects With Stable Chronic Heart Failure
Lead Sponsor:
Mayo Clinic
Conditions:
Stable Chronic Heart Failure
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
This human physiologic study will evaluate the effects of a new drug called CD-NP in individuals with stable chronic heart failure, with a focus on evaluating responses of the kidneys and the hormonal...
Detailed Description
CD-NP is a novel chimeric natriuretic peptide which was created by combining the 22 amino acids of human C-type natriuretic peptide (CNP) and the 15-amino-acid C-terminus of Dendroaspis natriuretic pe...
Eligibility Criteria
Inclusion
- Male and non-pregnant female subjects, aged 21 or above, with stable chronic HF of primary cardiac etiology, resting left ventricular ejection fraction (LVEF) ≤ 40 % documented within the last 2 years, and New York Heart Association functional class I - III symptoms
- Be willing to provide informed consent.
Exclusion
- Known allergy or other adverse reactions to exogenous natriuretic peptides (CD-NP or its components, nesiritide, other natriuretic peptides, or related compounds).
- Women who are pregnant, or breast-feeding.
- Having received nesiritide for within 7 days prior to prior to entry into the study.
- Having received any investigational drug or device within 30 days prior to entry into the study.
- Clinically unstable patients (e.g. systolic blood pressure \< 90 mmHg, ongoing requirement for vasopressors or mechanical circulatory support, or mechanical ventilation).
- Recent hospitalization for decompensated HF or recent defibrillation for cardiac resuscitation within 30 days prior to randomization.
- Prior organ transplantation, being on a waiting list for organ transplantation, or ongoing requirement for longterm vasoactive support.
- Patients with guarded prognosis who are unlikely to derive meaningful benefit from CD-NP.
- Use of sulfonamides, non-steroidal anti-inflammatory drugs, probenecid, or other drugs that are known to alter renal function within 5 half-lives prior to the first dose of CD-NP or placebo.
- Presence of cardiac lesions or comorbidities that may contraindicate the use of natriuretic peptides, such as clinically significant cardiac valvular stenosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or uncorrected congenital heart disease that contraindicates the use of vasodilators.
- History of blood pressure \> 190/115 mmHg or unexplained syncope within the past 3 months.
- Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months
- Clinically significant renal artery stenosis
- Baseline hemoglobin \< 10.0 g/dL.
- Serum sodium \< 130 mEq/L, potassium \< 3.6 mEq/L, or magnesium \< 1.7 mEq/L.
- Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at least 5 times the upper limit of normal or bilirubin at least 3 times the upper limit of normal
- Creatinine clearance (CrCl) \< 50 ml.min-1.1.73m-2, as calculated by Cockcroft-Gault formula and adjusted for body surface area within the past year or at screening, or requirement for dialysis.
- History of alcohol abuse within the past 6 months.
- Consumption of a phosphodiesterase-5 inhibitor (sildenafil, vardenafil, or tadalafil) within 72 hours of receiving CD-NP or placebo.
- Inability to communicate effectively with study personnel.
- bmi\>38
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00620308
Start Date
June 1 2008
End Date
February 1 2012
Last Update
September 10 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905