Evaluation of the renal hemodynamic responses to intravenous RLX030 infusion in patients with chronic heart failure.

A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the renal hemodynamic effects of RLX030 at a dose of 30 µg/kg/day or placebo infused for 24 hours in subjects with chronic heart failure (CHF).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001588-37-DE

Enrollment

Registered

2011-09-08

Start date

2011-11-29

Completion date

Unknown

Last updated

2013-07-15

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

Conditions

Chronic heart failure with worsening of symptoms like shortness of breath at rest or minimal exertion MedDRA version: 14.1 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849

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: - Chronic heart failure - On optimal standard therapy including a stable dose of loop diuretics - Reduced systolic function (LVEF = 45%) - BNP = 100 pg/mL or NT-pro-BNP of = 400 pg/mL - NYHA Class II or III - Worsening symptoms, e.g. fatigue and dyspnea - Impaired renal function defined as an estimated glomerular filtration Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes - Women of child-bearing potential unless they are using effective methods of contraception - Pregnant or nursing (lactating) women - Systolic blood pressure < 110 mm Hg - Current use of NSAIDs - Significant liver impairment - Significant lung impairment - Significant heart valve dysfunction or arrythmias - Myocaridal infarction or acute coronary syndrome within the last 45 days - History of hypersensitivity to iodine or shellfish

Design outcomes

Primary

Measure	Time frame
Main Objective: -To assess the effects of i.v. infusion of RLX030 compared to placebo on renal blood flow in patients with chronic heart failure. -To assess the effects of i.v. infusion of RLX030 compared to placebo on glomerular filtration rate in patients with chronic heart failure. ;Secondary Objective: - To assess the effects of i.v. infusion of RLX030 compared to placebo on diuresis and fractional sodium clearance in patients with chronic 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 chronic heart failure. - To assess the pharmacokinetics of RLX030 administered as i.v. infusion in patients with chronic heart failure. - To assess the overall safety and tolerability of RLX030 administered as i.v. infusion in patients with chronic heart failure. -To assess the effects of RLX030 30µg/kg/day compared to placebo on ECG intervals;Primary end point(s): - Renal Blood flow (RBF), - Glomerular Filtration rate (GFR) ;Timepoint(s) of evaluation of this end point: At baseline, at 2, 4, 6, 8, 20, 22, 24, 26, and 28 hours after start of infusion of study drug	—

Measure

Time frame

Main Objective: -To assess the effects of i.v. infusion of RLX030 compared to placebo on renal blood flow in patients with chronic heart failure. -To assess the effects of i.v. infusion of RLX030 compared to placebo on glomerular filtration rate in patients with chronic heart failure. ;Secondary Objective: - To assess the effects of i.v. infusion of RLX030 compared to placebo on diuresis and fractional sodium clearance in patients with chronic 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 chronic heart failure. - To assess the pharmacokinetics of RLX030 administered as i.v. infusion in patients with chronic heart failure. - To assess the overall safety and tolerability of RLX030 administered as i.v. infusion in patients with chronic heart failure. -To assess the effects of RLX030 30µg/kg/day compared to placebo on ECG intervals;Primary end point(s): - Renal Blood flow (RBF), - Glomerular Filtration rate (GFR) ;Timepoint(s) of evaluation of this end point: At baseline, at 2, 4, 6, 8, 20, 22, 24, 26, and 28 hours after start of infusion of study drug

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: a. At baseline, at 2, 4, 6, 8, 20, 22, 24, 26, and 28 hours after start of infusion of study drug b. At baseline, at 10, 30 minutes, and 2, 8, 20, 22, 24, 28 and 48 hours after start of infusion of study drug c. At baseline and at 8, 24, and 48 hours after start of infusion of study drug 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 48 hours after start of infusion of study drug ;Secondary end point(s): a. non-invasive measurement of central aortic systolic pressure and radial arterial pulse waveform b. Pharmacokinetics c. Selected biomarkers d. Safety and tolerability	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: a. At baseline, at 2, 4, 6, 8, 20, 22, 24, 26, and 28 hours after start of infusion of study drug b. At baseline, at 10, 30 minutes, and 2, 8, 20, 22, 24, 28 and 48 hours after start of infusion of study drug c. At baseline and at 8, 24, and 48 hours after start of infusion of study drug 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 48 hours after start of infusion of study drug ;Secondary end point(s): a. non-invasive measurement of central aortic systolic pressure and radial arterial pulse waveform b. Pharmacokinetics c. Selected biomarkers d. Safety and tolerability

—

Countries

Germany, Netherlands, Poland, United States

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