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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000833-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLX030 | Experimental | RLX030 as intravenous infusion for 20 hours |
|
| Placebo | Placebo Comparator | Matching placebo as intravenous infusion for 20 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLX030 | Drug | Intravenous infusion of RLX030 over 20 hrs |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change over time of systemic vascular resistance (SVR) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Buenos Aires | Buenos Aires | B1846BMF | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24255129 | Derived | 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. |
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| Placebo | Drug | Intravenous infusion of placebo over 20 hours |
|
Measurements will be made using a Swan-Ganz indwelling catheter |
| During 20 hours of infusion and up to 4 hours after stop of infusion |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change over time in Diuresis | Urine samples will be collected for analyses. | During 20 hours of infusion and 4 hours after stop of infusion |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| C577649 | serelaxin protein, human |
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