Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

August 4, 2014 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1846BMF
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1180AAX
        • Novartis Investigative Site
  • Germany
      • 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
        • Novartis Investigative Site
  • Italy
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Novartis Investigative Site
  • Poland
      • Warszawa, Poland, 04-628
        • Novartis Investigative Site
      • Wroclaw, Poland, 50-981
        • Novartis Investigative Site
  • Russian Federation
      • 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
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 87 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RLX030
RLX030 as intravenous infusion for 20 hours
Drug: RLX030
Intravenous infusion of RLX030 over 20 hrs
Other Names:
  • serelaxin*
  • *International Nonproprietary Name
PLACEBO_COMPARATOR: Placebo
Matching placebo as intravenous infusion for 20 hours.
Drug: Placebo
Intravenous infusion of placebo over 20 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, after 8 and 20 hrs treatment
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
baseline, after 8 and 20 hrs treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During 20 hours of infusion and up to 4 hours after stop of infusion
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
During 20 hours of infusion and up to 4 hours after stop of infusion
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
During 20 hours of infusion and up to 4 hours after stop of infusion
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
During 20 hours of infusion and up to 4 hours after stop of infusion
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
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)
Time Frame: During 20 hours of infusion and 24 hours after stop of infusion
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)
Time Frame: During 20 hours of infusion and 24 hours after stop of infusion
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)
Time Frame: During 20 hours of infusion and 24 hours after stop of infusion
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)
Time Frame: During 20 hours of infusion and 24 hours after stop of infusion
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)
Time Frame: During 20 hours of infusion and 24 hours after stop of infusion
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
Time Frame: During 20 hours of infusion and 24 hours after stop of infusion
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
Time Frame: During 20 hours of infusion and 4 hours after stop of infusion
Urine samples will be collected for analyses.
During 20 hours of infusion and 4 hours after stop of infusion
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.
During 20 hours of infusion and 4 hours after stop of infusion
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
During 20 hours of infusion and 24 hours after stop of infusion
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
During 20 hours of infusion and 24 hours after stop of infusion
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.
During 20 hours of infusion and 24 hours after stop of infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (ESTIMATE)

March 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRLX030A2201
  • 2011-000833-35 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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