CD-NP in Subjects With Stable Chronic Heart Failure

NCT00620308 | Completed Phase 1 DMC

• 1 other identifier: 07-005523
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 system.

Conditions

Stable Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• To assess renal, neurohumoral and non-invasive hemodynamic physiologic parameters

  Within the first 24 to 36 hours of the study and at follow-up visits (days 9 and 30)

Study Arms (3)

CD-NP low-dose study drug

EXPERIMENTAL

Drug: CD-NP

CD-NP high-dose study drug

EXPERIMENTAL

Drug: CD-NP

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CD-NP DRUG

One of two dosage levels (20 ng/kg/min and another level to be finalized) as a continuous intravenous infusion for four hours

CD-NP high-dose study drug; CD-NP low-dose study drug

Placebo DRUG

Dextrose 5% in water (the vehicle)

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• John C. Burnett, Jr., MD

  Mayo Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John Schirger ,MD

Study Record Dates

• First Submitted: February 10, 2008
• First Posted: February 21, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 10, 2012

Record last verified: 2012-08

Locations

US (1)