Hemodynamic responses to intravenous RLX030 infusion in patients with acute heart failure

A multicenter, phase II, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000833-35-DE

Enrollment

Registered

2011-06-27

Start date

2011-10-24

Completion date

Unknown

Last updated

2015-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure MedDRA version: 14.1 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Code: RLX030 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: RLX030 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients admitted to hospital or who require admission to hospital for management of acute heart failure with shortness of breath at rest or minimal exertion - stabilized within 2 days after admission - normal or elevated systolic blood pressure - elevated pulmonary capilary wedge pressure measured by Swan-Ganz catheterization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: - severe renal impairment - significant liver impairment - significant lung impairment - significant heart valve dysfunction or arrythmias - myocardial infarction or acute coronary syndrome within th elast 45 days

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effects on hemodynamic variables of RLX030 administered as i.v. infusion in patients with acute heart failure ;Secondary Objective: - To assess the on-set and off-set effects of RLX030 administered as i.v. infusion in patients with acute heart failure - To assess the effects of RLX030 administered as i.v. infusion on diuresis and creatinine clearance in patients with acute heart failure - To assess the effects of RLX030 administered as i.v. infusion on central aortic systolic pressure and radial arterial pulse waveform in patients with acute heart failure - To assess the pharmacokinetics of RLX030 administered as i.v. infusion in patients with acute heart failure - To assess the overall safety and tolerability of RLX030 administered as i.v. infusion in patients with acute heart failure ;Primary end point(s): - Pulmonary capillary wedge pressure (PCWP), - Right atrial pressure (RAP), - Systolic and diastolic pulmonary artery pressure (PAP), - Pulmonary oxygen saturation (pO2) and - Cardiac output (CO) ;Timepoint(s) of evaluation of this end point: At baseline, at 30 minutes, and 2, 4, 6, 8, 20, 22, and 24 hours after start of infusion of study drug	—

Measure

Time frame

Main Objective: To assess the effects on hemodynamic variables of RLX030 administered as i.v. infusion in patients with acute heart failure ;Secondary Objective: - To assess the on-set and off-set effects of RLX030 administered as i.v. infusion in patients with acute heart failure - To assess the effects of RLX030 administered as i.v. infusion on diuresis and creatinine clearance in patients with acute heart failure - To assess the effects of RLX030 administered as i.v. infusion on central aortic systolic pressure and radial arterial pulse waveform in patients with acute heart failure - To assess the pharmacokinetics of RLX030 administered as i.v. infusion in patients with acute heart failure - To assess the overall safety and tolerability of RLX030 administered as i.v. infusion in patients with acute heart failure ;Primary end point(s): - Pulmonary capillary wedge pressure (PCWP), - Right atrial pressure (RAP), - Systolic and diastolic pulmonary artery pressure (PAP), - Pulmonary oxygen saturation (pO2) and - Cardiac output (CO) ;Timepoint(s) of evaluation of this end point: At baseline, at 30 minutes, and 2, 4, 6, 8, 20, 22, and 24 hours after start of infusion of study drug

—

Secondary

Measure	Time frame
Secondary end point(s): a.Non-invasive measurement of central aortic systolic pressure and radial arterial pulse waveform b.Pharmacokinetics c.Total urine volume d.Safety and tolerability e.Sodium and creatinine excretion ;Timepoint(s) of evaluation of this end point: a. At baseline, at 30 minutes, and 2, 4, 6, 8, 20, 22, and 24 hours after start of infusion of study drug b. At baseline, at 10, 30 minutes, and 2, 8, 20, 22, 24, 27 and 44 hoursand on Day 30 after start of infusion of study drug c.AE/SAE monitoring d. Safety biochemistry and hematology samples taken at baseline and at 8, 20, and 24 hours after start of infusion of study drug and whenever clinically indicated. Blood pressure measured together with central aortic systolic pressure (see. a.) and ECG taken at baseline and at 8, 20, 24, and 44 hours after start of infusion of study drug	—

Measure

Time frame

Secondary end point(s): a.Non-invasive measurement of central aortic systolic pressure and radial arterial pulse waveform b.Pharmacokinetics c.Total urine volume d.Safety and tolerability e.Sodium and creatinine excretion ;Timepoint(s) of evaluation of this end point: a. At baseline, at 30 minutes, and 2, 4, 6, 8, 20, 22, and 24 hours after start of infusion of study drug b. At baseline, at 10, 30 minutes, and 2, 8, 20, 22, 24, 27 and 44 hoursand on Day 30 after start of infusion of study drug c.AE/SAE monitoring d. Safety biochemistry and hematology samples taken at baseline and at 8, 20, and 24 hours after start of infusion of study drug and whenever clinically indicated. Blood pressure measured together with central aortic systolic pressure (see. a.) and ECG taken at baseline and at 8, 20, 24, and 44 hours after start of infusion of study drug

—

Countries

Argentina, Germany, Italy, Netherlands, Poland, Russian Federation

Contacts

Public ContactMedizinischer Service

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026