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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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