Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure
NCT ID: NCT01543854
Last Updated: 2014-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2012-03-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RLX030
RLX030 as intravenous infusion for 20 hours
RLX030
Intravenous infusion of RLX030 over 20 hrs
Placebo
Matching placebo as intravenous infusion for 20 hours.
Placebo
Intravenous infusion of placebo over 20 hours
Interventions
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RLX030
Intravenous infusion of RLX030 over 20 hrs
Placebo
Intravenous infusion of placebo over 20 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pulmonary wedge pressure above or equal to18 mmHg determined by right heart catheterization
Exclusion Criteria
* 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
18 Years
87 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina
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, , Germany
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Wroclaw, , Poland
Novartis Investigative Site
Kemerovo, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
S.-Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Tomsk, , Russia
Countries
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References
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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.
Other Identifiers
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2011-000833-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRLX030A2201
Identifier Type: -
Identifier Source: org_study_id
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