AzTrials
AzTrials

Chronic Heart Failure (CHF)Phase 2NCT01546532

Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF)

A Phase 2 study testing RLX030 in people with Chronic Heart Failure (CHF), run by Novartis Pharmaceuticals at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure (CHF)
What is being tested?
RLX030
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
15 sitesin 4 countries
Study dates
Feb 2012to Dec 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

Poland7 sites

  • Novartis Investigative Site

    Grodzisk Mazowiecki, 05-825

  • Novartis Investigative Site

    Katowice, 40-637

  • Novartis Investigative Site

    Krakow, 31-202

  • Novartis Investigative Site

    Krakow, 31-501

  • Novartis Investigative Site

    Lublin, 20-954

  • Novartis Investigative Site

    Wałbrzych, 58-309

  • Novartis Investigative Site

    Warsaw, 04-628

Other trials in Poland

Germany4 sites

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hamburg, 20246

Other trials in Germany

Netherlands3 sites

  • Novartis Investigative Site

    Deventer, 7416 SE

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Sneek, 8601 ZR

Other trials in Netherlands

United States1 site

  • Novartis Investigative Site

    Baltimore, Maryland

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Renal Hemodynamic Effects of RLX030 and Placebo Infused for 24 Hours in Subjects With Chronic Heart Failure (CHF)

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.

Being tested
RLX030, Placebo
Keywords
Heart failure, RLX030, hemodynamics, cardiovascular diseases
Medical subject headings
Heart Failure, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RLX030Drug

    RLX030 as intravenous infusion for 24 hours.

  • PlaceboDrug

    Intravenous infusion of Placebo over 24 hours

Study groups in NCT01546532
Study groupRoleWhat they receive
RLX030ExperimentalRLX030 as intravenous infusion for 24 hours.
Receives: Drug: RLX030
PlaceboPlacebo comparatorPlacebo as intravenous infusion for 24 hours.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

Secondary outcomes (15)

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

    The filtration fraction (FF) is derived as the ratio of GFR divided by RBF in percent.

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

  2. Change over time in Diuresis

    Urine samples will be collected for analyses.

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

  3. Change over time in calculated creatinine clearance

    Urine samples will be collected for analyses.

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

  4. Change over time on fractional sodium excretion(natriuresis)

    Urine samples will be collected for analyses.

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

  5. 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

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

  6. Radial augmentation index-time curve

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

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

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

    Monitoring of adverse events, serious adverse events and death from screening to end of study

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

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

    Blood will be collected from an indwelling catheter.

    Measured: During 24 hours of infusion and for 24 hours after the end of infusion

  9. 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 indwelling catheter.

    Measured: During 24 hours of infusion and for 24 hours after the end of infusion

  10. Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C24h)

    Blood will be collected from an indwelling catheter.

    Measured: During 24 hours of infusion and for 24 hours after the end of infusion

  11. Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)following intravenous administration

    Blood will be collected from an indwelling catheter.

    Measured: During 24 hours of infusion and for 24 hours after the end of infusion

  12. Pharmacokinetics of RLX030: mean residence time (MRT)intravenous administration

    Blood will be collected from an indwelling catheter.

    Measured: During 24 hours of infusion and for 24 hours after the end of infusion

  13. Pharmacokinetics of RLX030: volume of distribution at steady state (Vss) following intravenous administration

    Blood will be collected from an indwelling catheter.

    Measured: During 24 hours of infusion and for 24 hours after the end of infusion

  14. Pharmacokinetics of RLX030: systemic clearance from serum (CL) following intravenous administration(natriuresis)

    Blood will be collected from an indwelling catheter.

    Measured: During 24 hours of infusion and for 24 hours after the end of infusion

  15. Corrected QT (QTc) Interval Using Fridericia's and Bazett's Formula

    Continuous 12 lead Holter ECG monitoring for extraction of ECGs and analysis

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01546532
Sponsor's protocol ID
CRLX030A2202
Other IDs
2011-001588-37
Status last verified
Feb 2013
First submitted
2 Mar 2012
Last updated
19 Dec 2020
Results posted
No

Publications

  • 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.

    PubMed 25286914

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RLX030 in people with Chronic Heart Failure (CHF), run by Novartis Pharmaceuticals at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Poland, Germany, Netherlands, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, during and after the end of 24 hours infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01546532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in