Acute Heart Failure
Conditions
Keywords
Heart failure, RLX030, Hemodynamics, Cardiovascular Diseases
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.
Interventions
DRUGRLX030
Intravenous infusion of RLX030 over 20 hrs
DRUGPlacebo
Intravenous infusion of placebo over 20 hours
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 87 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak change from baseline of PCWP (pulmonary capillary wedge pressure) | baseline, after 8 and 20 hrs treatment | Measurements will be made using a Swan-Ganz indwelling catheter |
| Peak change from baseline of CI (cardiac index) | baseline, after 8 and 20 hrs treatment | Measurements will be made using a Swan-Ganz indwelling catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change over time of pulmonary vascular resistance (PVR) | During 20 hours of infusion and up to 4 hours after stop of infusion | Measurements will be made using a Swan-Ganz indwelling catheter |
| Change over time of pulmonary arterial pressure (PAP) | During 20 hours of infusion and up to 4 hours after stop of infusion | Hemodynamic measurements were made using a Swan-Ganz catheter when patients were in a supine position |
| Change over time of pulmonary and peripheral oxygen saturation | During 20 hours of infusion and up to 4 hours after stop of infusion | Hemodynamic measurements were made using a Swan-Ganz catheter when patients were in a supine position |
| Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to infinity (AUCinf) | During 20 hours of infusion and 24 hours after stop of infusion | 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) | During 20 hours of infusion and 24 hours after stop of infusion | Blood will be collected from an in dwelling catheter. |
| Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h) | During 20 hours of infusion and 24 hours after stop of infusion | Blood will be collected from an in dwelling catheter. |
| Pharmacokinetics of RLX030: terminal elimination half-life (T1/2) | During 20 hours of infusion and 24 hours after stop of infusion | Blood will be collected from an in dwelling catheter. |
| Change over time of PCWP (pulmonary capillary wedge pressure) | During 20 hours of infusion and up to 4 hours after stop of infusion | Measurements will be made using a Swan-Ganz indwelling catheter |
| Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration | During 20 hours of infusion and 24 hours after stop of infusion | Blood will be collected from an in dwelling catheter. |
| Change over time on calculated creatinine clearance | During 20 hours of infusion and 4 hours after stop of infusion | Urine samples will be collected for analyses. |
| Change over time in Diuresis | During 20 hours of infusion and 4 hours after stop of infusion | Urine samples will be collected for analyses. |
| Central aortic systolic pressure-time curve | During 20 hours of infusion and 24 hours after stop of infusion | A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms |
| Radial augmentation index-time curve | During 20 hours of infusion and 24 hours after stop of infusion | 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 | During 20 hours of infusion and 24 hours after stop of infusion | Adverse events will be assessed by signs/symptoms, clinical laboratory and electrocardiographs. |
| Pharmacokinetics of RLX030: mean residence time (MRT) | During 20 hours of infusion and 24 hours after stop of infusion | Blood will be collected from an in dwelling catheter. |
| Change over time of systemic vascular resistance (SVR) | During 20 hours of infusion and up to 4 hours after stop of infusion | Measurements will be made using a Swan-Ganz indwelling catheter |
Countries
Argentina, Germany, Italy, Netherlands, Poland, Russia
Outcome results
None listed