Phase 2 N=61 Randomized Treatment

An Exploratory Study of Nesiritide in Participants With Acute Heart Failure

Heart Failure, Congestive

Bottom Line

View on ClinicalTrials.gov: NCT00490724 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Feb 2014

Primary outcome: Primary: Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours — 27.7; 24.8; 29.7; -6.7 Millimeters of Mercury (mmHg)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Nesiritide (1+0.01) (Drug); Nesiritide (2+0.005) (Drug); Nesritide (2+0.01) (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Janssen Pharmaceutical K.K.
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours	27.7; 24.8; 29.7; -6.7; -5.4; -6.2	—
SECONDARY Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour	14.5; 10.3; 13.1; -1.9; -2.5; -2.6	—
SECONDARY Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour	55.9; 51.3; 59.8; -3.6; -8.2; -4.2	—
SECONDARY Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour	26.5; 24.2; 30.1; -1.6; -6.1; -4.6	—
SECONDARY Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour	38.2; 34.5; 42.6; -2.3; -7.0; -4.9	—
SECONDARY Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour	27.0; 24.3; 30.2; -3.5; -5.5; -5.1	—
SECONDARY Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour	4.4026; 3.9768; 4.0971; 0.2947; 0.5686; 0.2912	—
SECONDARY Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour	109.397; 106.169; 105.006; -6.053; -9.167; -7.098	—
SECONDARY Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour	2.712; 2.356; 2.382; 0.199; 0.305; 0.232	—
SECONDARY Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour	48.368; 49.126; 41.545; 4.122; 3.305; 3.517	—
SECONDARY Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour	29.683; 28.655; 24.483; 2.888; 1.853; 2.584	—
SECONDARY Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour	1935.318; 2170.633; 2062.369; -261.453; -366.981; -384.379	—
SECONDARY Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour	215.736; 208.714; 239.383; -19.361; -40.647; -12.482	—
SECONDARY Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score	1; 2; 4; 0; 1; 0	—
SECONDARY Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score	5; 4; 6; 2; 4; 2	—
SECONDARY Number of Participants With Orthopnea	6; 4; 4; 7; 7; 1	—
SECONDARY Number of Participants With Oxygen Therapy	16; 20; 17; 2; 0; 0	—
SECONDARY Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2)	96.5; 96.4; 96.9; 96.6; 96.6; 96.4	—
SECONDARY Assessment of Dyspnea Using Respiratory Rate	24.7; 25.6; 23.8; 24.0; 23.0; 22.6	—
SECONDARY Urinary Volume	83.9; 67.0; 79.7; 539.9; 423.6; 545.1	—

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

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Data sourced from ClinicalTrials.gov (NCT00490724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.