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Completed

NCT Number: NCT01543854

Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

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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Key information

Conditions

Acute Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RLX030

Drug

Intravenous infusion of RLX030 over 20 hrs

Other names: serelaxin*, *International Nonproprietary Name

Placebo

Drug

Intravenous infusion of placebo over 20 hours

Primary outcomes

  1. Peak change from baseline of PCWP (pulmonary capillary wedge pressure)

    Time frame: baseline, after 8 and 20 hrs treatment

    Measurements will be made using a Swan-Ganz indwelling catheter

  2. Peak change from baseline of CI (cardiac index)

    Time frame: baseline, after 8 and 20 hrs treatment

    Measurements will be made using a Swan-Ganz indwelling catheter

Secondary outcomes

  1. 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

    Measurements will be made using a Swan-Ganz indwelling catheter

  2. Change over time of systemic vascular resistance (SVR)

    Time frame: During 20 hours of infusion and up to 4 hours after stop of infusion

    Measurements will be made using a Swan-Ganz indwelling catheter

  3. Change over time of pulmonary vascular resistance (PVR)

    Time frame: During 20 hours of infusion and up to 4 hours after stop of infusion

    Measurements will be made using a Swan-Ganz indwelling catheter

  4. Change over time of pulmonary arterial pressure (PAP)

    Time frame: 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

  5. 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

    Hemodynamic measurements were made using a Swan-Ganz catheter when patients were in a supine position

  6. 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

    Blood will be collected from an in dwelling catheter.

  7. 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

    Blood will be collected from an in dwelling catheter.

  8. 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

    Blood will be collected from an in dwelling catheter.

  9. Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)

    Time frame: During 20 hours of infusion and 24 hours after stop of infusion

    Blood will be collected from an in dwelling catheter.

  10. Pharmacokinetics of RLX030: mean residence time (MRT)

    Time frame: During 20 hours of infusion and 24 hours after stop of infusion

    Blood will be collected from an in dwelling catheter.

  11. 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

    Blood will be collected from an in dwelling catheter.

  12. Change over time on calculated creatinine clearance

    Time frame: During 20 hours of infusion and 4 hours after stop of infusion

    Urine samples will be collected for analyses.

  13. Change over time in Diuresis

    Time frame: During 20 hours of infusion and 4 hours after stop of infusion

    Urine samples will be collected for analyses.

  14. Central aortic systolic pressure-time curve

    Time frame: 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

  15. Radial augmentation index-time curve

    Time frame: 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

  16. 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

    Adverse events will be assessed by signs/symptoms, clinical laboratory and electrocardiographs.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2012
Registry last updated
Aug 5, 2014

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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