Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

Phase 2

Completed

• Conditions: Acute Heart Failure
• Interventions: Drug: RLX030; Drug: Placebo

• Registration Number: NCT01543854
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-28
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RLX030	RLX030	RLX030 as intravenous infusion for 20 hours
Placebo	Placebo	Matching placebo as intravenous infusion for 20 hours.

Primary Outcome Measures

Name	Time	Method
Peak change from baseline of PCWP (pulmonary capillary wedge pressure)	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)	baseline, after 8 and 20 hrs treatment	Measurements will be made using a Swan-Ganz indwelling catheter

Secondary Outcome Measures

Name	Time	Method
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	Blood will be collected from an in dwelling catheter.
Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration	During 20 hours of infusion and 24 hours after stop of infusion	Blood will be collected from an in dwelling catheter.
Change over time of PCWP (pulmonary capillary wedge pressure)	During 20 hours of infusion and up to 4 hours after stop of infusion	Measurements will be made using a Swan-Ganz indwelling catheter
Change over time of systemic vascular resistance (SVR)	During 20 hours of infusion and up to 4 hours after stop of infusion	Measurements will be made using a Swan-Ganz indwelling catheter
Change over time of pulmonary arterial pressure (PAP)	During 20 hours of infusion and up to 4 hours after stop of infusion	Hemodynamic measurements were made using a Swan-Ganz catheter when patients were in a supine position
Change over time of pulmonary vascular resistance (PVR)	During 20 hours of infusion and up to 4 hours after stop of infusion	Measurements will be made using a Swan-Ganz indwelling catheter
Change over time of pulmonary and peripheral oxygen saturation	During 20 hours of infusion and up to 4 hours after stop of infusion	Hemodynamic measurements were made using a Swan-Ganz catheter when patients were in a supine position
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	Blood will be collected from an in dwelling catheter.
Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h)	During 20 hours of infusion and 24 hours after stop of infusion	Blood will be collected from an in dwelling catheter.
Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)	During 20 hours of infusion and 24 hours after stop of infusion	Blood will be collected from an in dwelling catheter.
Pharmacokinetics of RLX030: mean residence time (MRT)	During 20 hours of infusion and 24 hours after stop of infusion	Blood will be collected from an in dwelling catheter.
Change over time on calculated creatinine clearance	During 20 hours of infusion and 4 hours after stop of infusion	Urine samples will be collected for analyses.
Central aortic systolic pressure-time curve	During 20 hours of infusion and 24 hours after stop of infusion	A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms
Number of patients with adverse events, serious adverse events and death	During 20 hours of infusion and 24 hours after stop of infusion	Adverse events will be assessed by signs/symptoms, clinical laboratory and electrocardiographs.
Radial augmentation index-time curve	During 20 hours of infusion and 24 hours after stop of infusion	A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms
Change over time in Diuresis	During 20 hours of infusion and 4 hours after stop of infusion	Urine samples will be collected for analyses.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇷🇺 Tomsk, Russian Federation