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Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

Primary Purpose

Acute Heart Failure

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

RLX030

Placebo

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Heart failure, RLX030, Hemodynamics, Cardiovascular Diseases

Eligibility Criteria

18 Years - 87 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RLX030

Placebo

Arm Description

RLX030 as intravenous infusion for 20 hours

Matching placebo as intravenous infusion for 20 hours.

Outcomes

Primary Outcome Measures

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

Measurements will be made using a Swan-Ganz indwelling catheter

Peak change from baseline of CI (cardiac index)

Measurements will be made using a Swan-Ganz indwelling catheter

Secondary Outcome Measures

Change over time of PCWP (pulmonary capillary wedge pressure)

Measurements will be made using a Swan-Ganz indwelling catheter

Change over time of systemic vascular resistance (SVR)

Measurements will be made using a Swan-Ganz indwelling catheter

Change over time of pulmonary vascular resistance (PVR)

Measurements will be made using a Swan-Ganz indwelling catheter

Change over time of pulmonary arterial pressure (PAP)

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

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)

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)

Blood will be collected from an in dwelling catheter.

Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h)

Blood will be collected from an in dwelling catheter.

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

Blood will be collected from an in dwelling catheter.

Pharmacokinetics of RLX030: mean residence time (MRT)

Blood will be collected from an in dwelling catheter.

Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration

Blood will be collected from an in dwelling catheter.

Change over time on calculated creatinine clearance

Urine samples will be collected for analyses.

Change over time in Diuresis

Urine samples will be collected for analyses.

Central aortic systolic pressure-time curve

A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms

Radial augmentation index-time curve

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

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

Full Information

NCT ID

NCT01543854

First Posted

February 28, 2012

Last Updated

August 4, 2014

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01543854

Brief Title

Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure

Keywords

Heart failure, RLX030, Hemodynamics, Cardiovascular Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RLX030

Arm Type

Experimental

Arm Description

RLX030 as intravenous infusion for 20 hours

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo as intravenous infusion for 20 hours.

Intervention Type

Drug

Intervention Name(s)

RLX030

Other Intervention Name(s)

serelaxin*, *International Nonproprietary Name

Intervention Description

Intravenous infusion of RLX030 over 20 hrs

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous infusion of placebo over 20 hours

Primary Outcome Measure Information:

Title

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

Description

Measurements will be made using a Swan-Ganz indwelling catheter

Time Frame

baseline, after 8 and 20 hrs treatment

Title

Peak change from baseline of CI (cardiac index)

Description

Measurements will be made using a Swan-Ganz indwelling catheter

Time Frame

baseline, after 8 and 20 hrs treatment

Secondary Outcome Measure Information:

Title

Change over time of PCWP (pulmonary capillary wedge pressure)

Description

Measurements will be made using a Swan-Ganz indwelling catheter

Time Frame

During 20 hours of infusion and up to 4 hours after stop of infusion

Title

Change over time of systemic vascular resistance (SVR)

Description

Measurements will be made using a Swan-Ganz indwelling catheter

Time Frame

During 20 hours of infusion and up to 4 hours after stop of infusion

Title

Change over time of pulmonary vascular resistance (PVR)

Description

Measurements will be made using a Swan-Ganz indwelling catheter

Time Frame

During 20 hours of infusion and up to 4 hours after stop of infusion

Title

Change over time of pulmonary arterial pressure (PAP)

Description

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

Time Frame

During 20 hours of infusion and up to 4 hours after stop of infusion

Title

Change over time of pulmonary and peripheral oxygen saturation

Description

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

Time Frame

During 20 hours of infusion and up to 4 hours after stop of infusion

Title

Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to infinity (AUCinf)

Description

Blood will be collected from an in dwelling catheter.

Time Frame

During 20 hours of infusion and 24 hours after stop of infusion

Title

Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)

Description

Blood will be collected from an in dwelling catheter.

Time Frame

During 20 hours of infusion and 24 hours after stop of infusion

Title

Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h)

Description

Blood will be collected from an in dwelling catheter.

Time Frame

During 20 hours of infusion and 24 hours after stop of infusion

Title

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

Description

Blood will be collected from an in dwelling catheter.

Time Frame

During 20 hours of infusion and 24 hours after stop of infusion

Title

Pharmacokinetics of RLX030: mean residence time (MRT)

Description

Blood will be collected from an in dwelling catheter.

Time Frame

During 20 hours of infusion and 24 hours after stop of infusion

Title

Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration

Description

Blood will be collected from an in dwelling catheter.

Time Frame

During 20 hours of infusion and 24 hours after stop of infusion

Title

Change over time on calculated creatinine clearance

Description

Urine samples will be collected for analyses.

Time Frame

During 20 hours of infusion and 4 hours after stop of infusion

Title

Change over time in Diuresis

Description

Urine samples will be collected for analyses.

Time Frame

During 20 hours of infusion and 4 hours after stop of infusion

Title

Central aortic systolic pressure-time curve

Description

A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms

Time Frame

During 20 hours of infusion and 24 hours after stop of infusion

Title

Radial augmentation index-time curve

Description

A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms

Time Frame

During 20 hours of infusion and 24 hours after stop of infusion

Title

Number of patients with adverse events, serious adverse events and death

Description

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

Time Frame

During 20 hours of infusion and 24 hours after stop of infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

87 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1180AAX

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

B1846BMF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

ZIP/Postal Code

99089

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle/'Saale

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04-628

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-981

Country

Poland

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127644

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

S.-Petersburg

ZIP/Postal Code

198205

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St-Petersburg

ZIP/Postal Code

198013

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

192242

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Tomsk

ZIP/Postal Code

634012

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

24255129

Citation

Ponikowski P, Mitrovic V, Ruda M, Fernandez A, Voors AA, Vishnevsky A, Cotter G, Milo O, Laessing U, Zhang Y, Dahlke M, Zymlinski R, Metra M. A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure. Eur Heart J. 2014 Feb;35(7):431-41. doi: 10.1093/eurheartj/eht459. Epub 2013 Nov 18.

Results Reference

derived

Learn more about this trial

Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

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Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

Acute Heart Failure

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial