An Exploratory Study of Nesiritide in Participants With Acute Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Intervention: Nesiritide (1+0.01); Nesiritide (2+0.005); Nesritide (2+0.01)
Intervention description: Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 15.4 to 35.2 mcg/kg.; Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 9.2 to 31.7 mcg/kg.; Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 16.4 to 36.2 mcg/kg.
Intervention MeSH terms: Natriuretic Peptide, Brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Heart failure, congestive; Nesiritide and; JNS004

Summary:

      The purpose of this exploratory study is to assess the efficacy and safety of nesiritide in
      participants with acute (a quick and severe form of illness in its early stage) heart failure
      (when the heart inadequately pumps blood through the body) including acute exacerbation of
      chronic (lasting a long time) heart failure, administered intravenous (into a vein) bolus (a
      large amount) followed by intravenous infusion (a fluid or a medicine delivered into a vein
      by way of a needle).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with acute heart failure (including acute exacerbation of chronic heart
             failure) requiring hospitalization whose placement of right-heart catheter (flexible,
             tube-like tool used to take fluids out or put fluids into the body) is judged to be
             possible and useful for treatment

          -  Participants with findings of pulmonary (having to do with the lungs) congestion on a
             chest X-ray (an image of a site produced on photographic film by X-rays passing
             through the site) film taken within 12 hours before starting the treatment

          -  Participants with 2 systolic blood pressure (SBP: refers to blood pressure [pressure
             of the blood on the arteries and other blood vessel] when the heart beats while
             pumping blood) values greater than or equal to 100 millimeters of mercury (mmHg)
             measured at an interval of at least 15 minutes in the hemodynamic (related to blood
             flow) assessment in observation period

          -  In a hemodynamic assessment in observation period, participants with 2 pulmonary
             capillary wedge pressure (PCWP [if it is not available, pulmonary arterial diastolic
             pressure {PADP}]) values greater than or equal to 18 mmHg measured at an interval of
             at least 15 minutes and the second measurement value is within positive 20 percent (%)
             and negative 20% compared with the first 1

        Exclusion Criteria:

          -  Participants with severe (very serious, life threatening) hepatic (to do with liver)
             impairment or renal (to do with kidney) impairment, cancer (abnormal tissue that grows
             and spreads in the body until it kills), or malignant (cancerous) tumor (a mass in a
             specific area)

          -  Participants who are or may be pregnant or breast-feeding

          -  Participants receiving non-invasive (puncture, opening or cutting of the skin)
             positive pressure ventilation (NIPPV) or scheduled to receive this during the study
             period

          -  Participants who received treatment with another investigational product within 4
             weeks before the initiation of investigational treatment or who were enrolled in a
             clinical study of nesiritide in the past

          -  Participants who received prohibited concomitant medications within 3 hours before the
             initiation of investigational treatment or those who are receiving such a medication