Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF)
NCT ID: NCT01546532
Last Updated: 2020-12-19
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
118 participants
INTERVENTIONAL
2012-02-29
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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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 24 hours.
RLX030
RLX030 as intravenous infusion for 24 hours.
Placebo
Placebo as intravenous infusion for 24 hours.
Placebo
Intravenous infusion of Placebo over 24 hours
Interventions
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RLX030
RLX030 as intravenous infusion for 24 hours.
Placebo
Intravenous infusion of Placebo over 24 hours
Eligibility Criteria
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Inclusion Criteria
* Male and female heart failure patients with body weight \<160 kg, on standard therapy including a stable dose of furosemide 40-240 mg/day orally (p.o). or equivalent dose of loop diuretics, reduced systolic function (LVEF ≤ 45% measured within the past 6 months), BNP ≥ 100 pg/mL or NT-pro-BNP of ≥ 400 pg/mLNYHA Class II or III, and worsening symptoms, e.g. fatigue, dyspnea, breathlessness within 3 months
* Mild to moderate renal impairment
Exclusion Criteria
* Administration of intravenous radiographic contrast agent within 72 hours prior to randomization or acute contrast-induced nephropathy at the time of randomization
* Current use of non-steroidal antiinflammatory drugs (NSAIDs)
* Current or planned (through the completion of study drug infusion) treatment with any i.v. therapies, including vasodilators (including nesiritide), positive inotropic agents, vasopressors, levosimendan, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device).
* Clinically significant hepatic impairment defined as hepatic encephalopathy of any degree or total bilirubin \> 50 μmol/l (3 mg/dl) or, if patient is not on warfarin therapy, INR \> 2.0 (or Prothrombin Time \> 2 \* ULN)
18 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
Baltimore, Maryland, United States
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Erlangen, , Germany
Novartis Investigative Site
Göttingen, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Deventer, , Netherlands
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Sneek, , Netherlands
Novartis Investigative Site
Grodzisk Mazowiecki, , Poland
Novartis Investigative Site
Katowice, , Poland
Novartis Investigative Site
Krakow, , Poland
Novartis Investigative Site
Krakow, , Poland
Novartis Investigative Site
Lublin, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Wałbrzych, , Poland
Countries
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References
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Voors AA, Dahlke M, Meyer S, Stepinska J, Gottlieb SS, Jones A, Zhang Y, Laurent D, Slart RH, Navis GJ. Renal hemodynamic effects of serelaxin in patients with chronic heart failure: a randomized, placebo-controlled study. Circ Heart Fail. 2014 Nov;7(6):994-1002. doi: 10.1161/CIRCHEARTFAILURE.114.001536. Epub 2014 Oct 6.
Related Links
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Results for CRLX030A2202 from the Novartis Clinical Trials website
Other Identifiers
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2011-001588-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRLX030A2202
Identifier Type: -
Identifier Source: org_study_id