Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

Acute Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543854
• Other study ID #: CRLX030A2201
• Secondary ID: 2011-000833-35
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2012
• Last updated: August 4, 2014
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: August 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: BfArM - the National Institute for Drugs and Medical productsPoland: Ministry of HealthItaly: Ministry of HealthRussia: Ministry of HealthArgentina: ANMAT - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 87 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• RLX030
Intravenous infusion of RLX030 over 20 hrs
• Placebo
Intravenous infusion of placebo over 20 hours

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Germany	Novartis Investigative Site	Bad Nauheim
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Greifswald
Germany	Novartis Investigative Site	Halle/'Saale
Italy	Novartis Investigative Site	Brescia	BS
Netherlands	Novartis Investigative Site	Groningen
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	S.-Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	St-Petersburg
Russian Federation	Novartis Investigative Site	St. Petersburg
Russian Federation	Novartis Investigative Site	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Germany,  Italy,  Netherlands,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak change from baseline of PCWP (pulmonary capillary wedge pressure)	Measurements will be made using a Swan-Ganz indwelling catheter	baseline, after 8 and 20 hrs treatment	No
Primary	Peak change from baseline of CI (cardiac index)	Measurements will be made using a Swan-Ganz indwelling catheter	baseline, after 8 and 20 hrs treatment	No
Secondary	Change over time of PCWP (pulmonary capillary wedge pressure)	Measurements will be made using a Swan-Ganz indwelling catheter	During 20 hours of infusion and up to 4 hours after stop of infusion	Yes
Secondary	Change over time of systemic vascular resistance (SVR)	Measurements will be made using a Swan-Ganz indwelling catheter	During 20 hours of infusion and up to 4 hours after stop of infusion	Yes
Secondary	Change over time of pulmonary vascular resistance (PVR)	Measurements will be made using a Swan-Ganz indwelling catheter	During 20 hours of infusion and up to 4 hours after stop of infusion	Yes
Secondary	Change over time of pulmonary arterial pressure (PAP)	Hemodynamic measurements were made using a Swan-Ganz catheter when patients were in a supine position	During 20 hours of infusion and up to 4 hours after stop of infusion	Yes
Secondary	Change over time of pulmonary and peripheral oxygen saturation	Hemodynamic measurements were made using a Swan-Ganz catheter when patients were in a supine position	During 20 hours of infusion and up to 4 hours after stop of infusion	Yes
Secondary	Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to infinity (AUCinf)	Blood will be collected from an in dwelling catheter.	During 20 hours of infusion and 24 hours after stop of infusion	No
Secondary	Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)	Blood will be collected from an in dwelling catheter.	During 20 hours of infusion and 24 hours after stop of infusion	No
Secondary	Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h)	Blood will be collected from an in dwelling catheter.	During 20 hours of infusion and 24 hours after stop of infusion	No
Secondary	Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)	Blood will be collected from an in dwelling catheter.	During 20 hours of infusion and 24 hours after stop of infusion	No
Secondary	Pharmacokinetics of RLX030: mean residence time (MRT)	Blood will be collected from an in dwelling catheter.	During 20 hours of infusion and 24 hours after stop of infusion	No
Secondary	Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration	Blood will be collected from an in dwelling catheter.	During 20 hours of infusion and 24 hours after stop of infusion	No
Secondary	Change over time on calculated creatinine clearance	Urine samples will be collected for analyses.	During 20 hours of infusion and 4 hours after stop of infusion	Yes
Secondary	Change over time in Diuresis	Urine samples will be collected for analyses.	During 20 hours of infusion and 4 hours after stop of infusion	Yes
Secondary	Central aortic systolic pressure-time curve	A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms	During 20 hours of infusion and 24 hours after stop of infusion	No
Secondary	Radial augmentation index-time curve	A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms	During 20 hours of infusion and 24 hours after stop of infusion	No
Secondary	Number of patients with adverse events, serious adverse events and death	Adverse events will be assessed by signs/symptoms, clinical laboratory and electrocardiographs.	During 20 hours of infusion and 24 hours after stop of infusion	Yes