NCT01546532

Brief Summary

This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with chronic heart failure. In addition safety and effects on renal function and biomarkers will be assessed.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
4 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 19, 2020

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

March 2, 2012

Last Update Submit

December 11, 2020

Conditions

Chronic Heart Failure (CHF)

Keywords

Heart failureRLX030hemodynamicscardiovascular diseases

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in renal plasma flow (RPF) measured by Para-aminohippuric acid (PAH) clearance in subjects with CHF after 24 hours intravenous (i.v) infusion of RLX030

    Serial blood and urine collections over time for determination of PAH and its clearance respectively

    Baseline, during and after the end of 24 hours infusion

  • Change from baseline in glomerular filtration rate (GFR) as measured by Iothalamate (IOTH) clearance in subjects with CHF after 24 hours i.v. infusion of RLX030

    Serial blood and urine collections over time for determination of IOTH and its clearance respectively

    Baseline, during and after the end of 24 hours infusion

Secondary Outcomes (15)

  • Change from baseline in filtration fraction (FF) in subjects with CHF after 24 hours infusion of RLX030

    Baseline, during and after the end of 24 hours of infusion

  • Change over time in Diuresis

    During 24 hours of infusion and after the end of the infusion

  • Change over time in calculated creatinine clearance

    During 24 hours of infusion and after the end of the infusion

  • Change over time on fractional sodium excretion(natriuresis)

    During 24 hours of infusion and after the end of the infusion

  • Central aortic systolic pressure-time curve

    During 24 hours of infusion and after the end of the infusion

  • +10 more secondary outcomes

Study Arms (2)

RLX030

EXPERIMENTAL

RLX030 as intravenous infusion for 24 hours.

Drug: RLX030

Placebo

PLACEBO COMPARATOR

Placebo as intravenous infusion for 24 hours.

Drug: Placebo

Interventions

RLX030DRUG

RLX030 as intravenous infusion for 24 hours.

RLX030
PlaceboDRUG

Intravenous infusion of Placebo over 24 hours

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent must be obtained before any assessment is performed.
  • Male and female heart failure patients with body weight \<160 kg, on standard therapy including a stable dose of furosemide 40-240 mg/day orally (p.o). or equivalent dose of loop diuretics, reduced systolic function (LVEF ≤ 45% measured within the past 6 months), BNP ≥ 100 pg/mL or NT-pro-BNP of ≥ 400 pg/mLNYHA Class II or III, and worsening symptoms, e.g. fatigue, dyspnea, breathlessness within 3 months
  • Mild to moderate renal impairment

You may not qualify if:

  • Systolic blood pressure (SBP) \< 110 mm Hg at the time of randomization
  • Administration of intravenous radiographic contrast agent within 72 hours prior to randomization or acute contrast-induced nephropathy at the time of randomization
  • Current use of non-steroidal antiinflammatory drugs (NSAIDs)
  • Current or planned (through the completion of study drug infusion) treatment with any i.v. therapies, including vasodilators (including nesiritide), positive inotropic agents, vasopressors, levosimendan, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device).
  • Clinically significant hepatic impairment defined as hepatic encephalopathy of any degree or total bilirubin \> 50 μmol/l (3 mg/dl) or, if patient is not on warfarin therapy, INR \> 2.0 (or Prothrombin Time \> 2 \* ULN)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Novartis Investigative Site

Baltimore, Maryland, United States

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Deventer, 7416 SE, Netherlands

Location

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

Location

Novartis Investigative Site

Sneek, 8601 ZR, Netherlands

Location

Novartis Investigative Site

Grodzisk Mazowiecki, 05-825, Poland

Location

Novartis Investigative Site

Katowice, 40-637, Poland

Location

Novartis Investigative Site

Krakow, 31-202, Poland

Location

Novartis Investigative Site

Krakow, 31-501, Poland

Location

Novartis Investigative Site

Lublin, 20-954, Poland

Location

Novartis Investigative Site

Warsaw, 04-628, Poland

Location

Novartis Investigative Site

Wałbrzych, 58-309, Poland

Location

Related Publications (1)

  • Voors AA, Dahlke M, Meyer S, Stepinska J, Gottlieb SS, Jones A, Zhang Y, Laurent D, Slart RH, Navis GJ. Renal hemodynamic effects of serelaxin in patients with chronic heart failure: a randomized, placebo-controlled study. Circ Heart Fail. 2014 Nov;7(6):994-1002. doi: 10.1161/CIRCHEARTFAILURE.114.001536. Epub 2014 Oct 6.

    PMID: 25286914DERIVED

Related Links

MeSH Terms

Conditions

Heart FailureCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 7, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 19, 2020

Record last verified: 2013-02

Locations

DE(4)NL(3)PL(7)US(1)