Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure
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
2 other identifiers
interventional
71
6 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2012
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedAugust 5, 2014
August 1, 2014
10 months
February 28, 2012
August 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (16)
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 vascular resistance (PVR)
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 and peripheral oxygen saturation
During 20 hours of infusion and up to 4 hours after stop of infusion
- +11 more secondary outcomes
Study Arms (2)
RLX030
EXPERIMENTALRLX030 as intravenous infusion for 20 hours
Placebo
PLACEBO COMPARATORMatching placebo as intravenous infusion for 20 hours.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Novartis Investigative Site
Buenos Aires, Buenos Aires, B1846BMF, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1180AAX, Argentina
Novartis Investigative Site
Bad Nauheim, 61231, Germany
Novartis Investigative Site
Berlin, 10117, Germany
Novartis Investigative Site
Dortmund, 44137, Germany
Novartis Investigative Site
Erfurt, 99089, Germany
Novartis Investigative Site
Greifswald, 17475, Germany
Novartis Investigative Site
Halle, 06120, Germany
Novartis Investigative Site
Brescia, BS, 25123, Italy
Novartis Investigative Site
Groningen, 9713 GZ, Netherlands
Novartis Investigative Site
Warsaw, 04-628, Poland
Novartis Investigative Site
Wroclaw, 50-981, Poland
Novartis Investigative Site
Kemerovo, 650002, Russia
Novartis Investigative Site
Moscow, 121552, Russia
Novartis Investigative Site
Moscow, 127644, Russia
Novartis Investigative Site
S.-Petersburg, 198205, Russia
Novartis Investigative Site
Saint Petersburg, 192242, Russia
Novartis Investigative Site
Saint Petersburg, 198013, Russia
Novartis Investigative Site
Saint Petersburg, 199106, Russia
Novartis Investigative Site
Tomsk, 634012, Russia
Related Publications (1)
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.
PMID: 24255129DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2012
First Posted
March 5, 2012
Study Start
March 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
August 5, 2014
Record last verified: 2014-08