Clinical trial NCT01543854: Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Heart Failure
Keywords: Heart failure
RLX030
Hemodynamics
Cardiovascular Diseases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Peak change from baseline of PCWP (pulmonary capillary wedge pressure)
timeFrame: baseline, after 8 and 20 hrs treatment
measure: Peak change from baseline of CI (cardiac index)
timeFrame: baseline, after 8 and 20 hrs treatment
Secondary outcomes:
measure: Change over time of PCWP (pulmonary capillary wedge pressure)
timeFrame: During 20 hours of infusion and up to 4 hours after stop of infusion
measure: Change over time of systemic vascular resistance (SVR)
timeFrame: During 20 hours of infusion and up to 4 hours after stop of infusion
measure: Change over time of pulmonary vascular resistance (PVR)
timeFrame: During 20 hours of infusion and up to 4 hours after stop of infusion
measure: Change over time of pulmonary arterial pressure (PAP)
timeFrame: During 20 hours of infusion and up to 4 hours after stop of infusion
measure: Change over time of pulmonary and peripheral oxygen saturation
timeFrame: During 20 hours of infusion and up to 4 hours after stop of infusion
measure: Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to infinity (AUCinf)
timeFrame: During 20 hours of infusion and 24 hours after stop of infusion
measure: Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
timeFrame: During 20 hours of infusion and 24 hours after stop of infusion
measure: Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h)
timeFrame: During 20 hours of infusion and 24 hours after stop of infusion
measure: Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)
timeFrame: During 20 hours of infusion and 24 hours after stop of infusion
measure: Pharmacokinetics of RLX030: mean residence time (MRT)
timeFrame: During 20 hours of infusion and 24 hours after stop of infusion
measure: Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration
timeFrame: During 20 hours of infusion and 24 hours after stop of infusion
measure: Change over time on calculated creatinine clearance
timeFrame: During 20 hours of infusion and 4 hours after stop of infusion
measure: Change over time in Diuresis
timeFrame: During 20 hours of infusion and 4 hours after stop of infusion
measure: Central aortic systolic pressure-time curve
timeFrame: During 20 hours of infusion and 24 hours after stop of infusion
measure: Radial augmentation index-time curve
timeFrame: During 20 hours of infusion and 24 hours after stop of infusion
measure: Number of patients with adverse events, serious adverse events and death
timeFrame: During 20 hours of infusion and 24 hours after stop of infusion
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Bad Nauheim
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Greifswald
country: Germany
facility: Novartis Investigative Site
city: Halle/'Saale
country: Germany
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: S.-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tomsk
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ponikowski P, Mitrovic V, Ruda M, Fernandez A, Voors AA, Vishnevsky A, Cotter G, Milo O, Laessing U, Zhang Y, Dahlke M, Zymlinski R, Metra M. A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure. Eur Heart J. 2014 Feb;35(7):431-41. doi: 10.1093/eurheartj/eht459. Epub 2013 Nov 18.