A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-controlled Study to Evaluate the Hemodynamic Responses to Intravenous RLX030 Infusion in Subjects With Acute Heart Failure

Novartis Pharmaceuticals1 site in 1 country71 target enrollmentMarch 2012

ConditionsAcute Heart Failure

InterventionsRLX030 Placebo

DrugsRLX030 Placebo

Overview

Phase: Phase 2
Intervention: RLX030
Conditions: Acute Heart Failure
Sponsor: Novartis Pharmaceuticals
Enrollment: 71
Locations: 1
Primary Endpoint: Peak change from baseline of PCWP (pulmonary capillary wedge pressure)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart failure. In addition safety and effects on renal function and biomarkers will be assessed.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

January 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients hospitalized or requiring admission to hospital for management of acute heart failure within the previous 48 hours.
•Pulmonary wedge pressure above or equal to18 mmHg determined by right heart catheterization

Exclusion Criteria

•Systolic blood pressure below 115 mmHg
•Significant valvular diseases or arrythmias
•Acute coronary syndrome in previous 45 days
•Treatment with mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
•Impaired renal or hepatic function
•Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

RLX030

RLX030 as intravenous infusion for 20 hours

Intervention: RLX030

Placebo

Matching placebo as intravenous infusion for 20 hours.

Intervention: Placebo

Outcomes

Primary Outcomes

Peak change from baseline of PCWP (pulmonary capillary wedge pressure)

Time Frame: baseline, after 8 and 20 hrs treatment

Measurements will be made using a Swan-Ganz indwelling catheter

Peak change from baseline of CI (cardiac index)

Time Frame: baseline, after 8 and 20 hrs treatment

Measurements will be made using a Swan-Ganz indwelling catheter

Secondary Outcomes

Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to infinity (AUCinf)(During 20 hours of infusion and 24 hours after stop of infusion)
Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration(During 20 hours of infusion and 24 hours after stop of infusion)
Change over time of PCWP (pulmonary capillary wedge pressure)(During 20 hours of infusion and up to 4 hours after stop of infusion)
Change over time of systemic vascular resistance (SVR)(During 20 hours of infusion and up to 4 hours after stop of infusion)
Change over time of pulmonary arterial pressure (PAP)(During 20 hours of infusion and up to 4 hours after stop of infusion)
Change over time of pulmonary vascular resistance (PVR)(During 20 hours of infusion and up to 4 hours after stop of infusion)
Change over time of pulmonary and peripheral oxygen saturation(During 20 hours of infusion and up to 4 hours after stop of infusion)
Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)(During 20 hours of infusion and 24 hours after stop of infusion)
Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h)(During 20 hours of infusion and 24 hours after stop of infusion)
Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)(During 20 hours of infusion and 24 hours after stop of infusion)
Change over time on calculated creatinine clearance(During 20 hours of infusion and 4 hours after stop of infusion)
Pharmacokinetics of RLX030: mean residence time (MRT)(During 20 hours of infusion and 24 hours after stop of infusion)
Central aortic systolic pressure-time curve(During 20 hours of infusion and 24 hours after stop of infusion)
Number of patients with adverse events, serious adverse events and death(During 20 hours of infusion and 24 hours after stop of infusion)
Radial augmentation index-time curve(During 20 hours of infusion and 24 hours after stop of infusion)
Change over time in Diuresis(During 20 hours of infusion and 4 hours after stop of infusion)