RLX030
DrugRLX030 as intravenous infusion for 24 hours.
NCT Number: NCT01546532
This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with chronic heart failure. In addition safety and effects on renal function and biomarkers will be assessed.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Novartis Investigative Site, Berlin, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
RLX030 as intravenous infusion for 24 hours.
Intravenous infusion of Placebo over 24 hours
Time frame: Baseline, during and after the end of 24 hours infusion
Serial blood and urine collections over time for determination of PAH and its clearance respectively
Time frame: Baseline, during and after the end of 24 hours infusion
Serial blood and urine collections over time for determination of IOTH and its clearance respectively
Time frame: Baseline, during and after the end of 24 hours of infusion
The filtration fraction (FF) is derived as the ratio of GFR divided by RBF in percent.
Time frame: During 24 hours of infusion and after the end of the infusion
Urine samples will be collected for analyses.
Time frame: During 24 hours of infusion and after the end of the infusion
Urine samples will be collected for analyses.
Time frame: During 24 hours of infusion and after the end of the infusion
Urine samples will be collected for analyses.
Time frame: During 24 hours of infusion and after the end of the infusion
A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms
Time frame: During 24 hours of infusion and after the end of the infusion
A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms
Time frame: During 24 hours of infusion and after the end of the infusion
Monitoring of adverse events, serious adverse events and death from screening to end of study
Time frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
Time frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
Time frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
Time frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
Time frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
Time frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
Time frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
Time frame: Baseline, during the 24 hours of infusion and after the end of the infusion
Continuous 12 lead Holter ECG monitoring for extraction of ECGs and analysis
Novartis Pharmaceuticals
Industry
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Renal Hemodynamic Effects of RLX030 and Placebo Infused for 24 Hours in Subjects With Chronic Heart Failure (CHF)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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