Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01543854
First received: February 28, 2012
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Heart Failure |
Drug: RLX030 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Peak change from baseline of PCWP (pulmonary capillary wedge pressure) [ Time Frame: baseline, after 8 and 20 hrs treatment ] [ Designated as safety issue: No ]Measurements will be made using a Swan-Ganz indwelling catheter
- Peak change from baseline of CI (cardiac index) [ Time Frame: baseline, after 8 and 20 hrs treatment ] [ Designated as safety issue: No ]Measurements will be made using a Swan-Ganz indwelling catheter
Secondary Outcome Measures:
- Change over time of PCWP (pulmonary capillary wedge pressure) [ Time Frame: During 20 hours of infusion and up to 4 hours after stop of infusion ] [ Designated as safety issue: Yes ]Measurements will be made using a Swan-Ganz indwelling catheter
- Change over time of systemic vascular resistance (SVR) [ Time Frame: During 20 hours of infusion and up to 4 hours after stop of infusion ] [ Designated as safety issue: Yes ]Measurements will be made using a Swan-Ganz indwelling catheter
- Change over time of pulmonary vascular resistance (PVR) [ Time Frame: During 20 hours of infusion and up to 4 hours after stop of infusion ] [ Designated as safety issue: Yes ]Measurements will be made using a Swan-Ganz indwelling catheter
- Change over time of pulmonary arterial pressure (PAP) [ Time Frame: During 20 hours of infusion and up to 4 hours after stop of infusion ] [ Designated as safety issue: Yes ]
- Change over time of pulmonary and peripheral oxygen saturation [ Time Frame: During 20 hours of infusion and up to 4 hours after stop of infusion ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: During 20 hours of infusion and 24 hours after stop of infusion ] [ Designated as safety issue: No ]Blood will be collected from an in dwelling catheter.
- Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [ Time Frame: During 20 hours of infusion and 24 hours after stop of infusion ] [ Designated as safety issue: No ]Blood will be collected from an in dwelling catheter.
- Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h) [ Time Frame: During 20 hours of infusion and 24 hours after stop of infusion ] [ Designated as safety issue: No ]Blood will be collected from an in dwelling catheter.
- Pharmacokinetics of RLX030: terminal elimination half-life (T1/2) [ Time Frame: During 20 hours of infusion and 24 hours after stop of infusion ] [ Designated as safety issue: No ]Blood will be collected from an in dwelling catheter.
- Pharmacokinetics of RLX030: mean residence time (MRT) [ Time Frame: During 20 hours of infusion and 24 hours after stop of infusion ] [ Designated as safety issue: No ]Blood will be collected from an in dwelling catheter.
- Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration [ Time Frame: During 20 hours of infusion and 24 hours after stop of infusion ] [ Designated as safety issue: No ]Blood will be collected from an in dwelling catheter.
- Change over time on calculated creatinine clearance [ Time Frame: During 20 hours of infusion and 4 hours after stop of infusion ] [ Designated as safety issue: Yes ]Urine samples will be collected for analyses.
- Change over time in Diuresis [ Time Frame: During 20 hours of infusion and 4 hours after stop of infusion ] [ Designated as safety issue: Yes ]Urine samples will be collected for analyses.
- Central aortic systolic pressure-time curve [ Time Frame: During 20 hours of infusion and 24 hours after stop of infusion ] [ Designated as safety issue: No ]A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms
- Radial augmentation index-time curve [ Time Frame: During 20 hours of infusion and 24 hours after stop of infusion ] [ Designated as safety issue: No ]A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms
- Number of patients with adverse events, serious adverse events and death [ Time Frame: During 20 hours of infusion and 24 hours after stop of infusion ] [ Designated as safety issue: Yes ]Adverse events will be assessed by signs/symptoms, clinical laboratory and electrocardiographs.
| Enrollment: | 120 |
| Study Start Date: | March 2012 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: RLX030
RLX030 as intravenous infusion for 20 hours
|
Drug: RLX030
Intravenous infusion of RLX030 over 20 hrs
Other Names:
|
|
Placebo Comparator: Placebo
Matching placebo as intravenous infusion for 20 hours.
|
Drug: Placebo
Intravenous infusion of placebo over 20 hours
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543854
Locations
| Argentina | |
| Novartis Investigative Site | |
| Buenos Aires, Capital Federal, Argentina, C1180AAX | |
| Novartis Investigative Site | |
| Buenos Aires, Argentina, B1846BMF | |
| Germany | |
| Novartis Investigative Site | |
| Bad Nauheim, Germany, 61231 | |
| Novartis Investigative Site | |
| Berlin, Germany, 10117 | |
| Novartis Investigative Site | |
| Dortmund, Germany, 44137 | |
| Novartis Investigative Site | |
| Erfurt, Germany, 99089 | |
| Novartis Investigative Site | |
| Greifswald, Germany, 17475 | |
| Novartis Investigative Site | |
| Halle/'Saale, Germany, 06120 | |
| Italy | |
| Novartis Investigative Site | |
| Brescia, BS, Italy, 25123 | |
| Netherlands | |
| Novartis Investigative Site | |
| Groningen, Netherlands, 9713 GZ | |
| Poland | |
| Novartis Investigative Site | |
| Warszawa, Poland, 04-628 | |
| Novartis Investigative Site | |
| Wroclaw, Poland, 50-981 | |
| Russian Federation | |
| Novartis Investigative Site | |
| Kemerovo, Russian Federation, 650002 | |
| Novartis Investigative Site | |
| Moscow, Russian Federation, 127644 | |
| Novartis Investigative Site | |
| Moscow, Russian Federation, 121552 | |
| Novartis Investigative Site | |
| S.-Petersburg, Russian Federation, 198205 | |
| Novartis Investigative Site | |
| Saint Petersburg, Russian Federation, 199106 | |
| Novartis Investigative Site | |
| St-Petersburg, Russian Federation, 198013 | |
| Novartis Investigative Site | |
| St. Petersburg, Russian Federation, 192242 | |
| Novartis Investigative Site | |
| Tomsk, Russian Federation, 634012 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01543854 History of Changes |
| Other Study ID Numbers: | CRLX030A2201, 2011-000833-35 |
| Study First Received: | February 28, 2012 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Germany: BfArM - the National Institute for Drugs and Medical products Poland: Ministry of Health Italy: Ministry of Health Russia: Ministry of Health Argentina: ANMAT - Ministry of Health |
Keywords provided by Novartis:
|
Heart failure RLX030 Hemodynamics Cardiovascular Diseases |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013