Acute Heart FailurePhase 2NCT01543854
Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure
A Phase 2 study testing RLX030 in people with Acute Heart Failure, run by Novartis Pharmaceuticals at 20 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 87 years
- Conditions the study is for
- Acute Heart Failure
- 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
- 71 participants
- Where
- 20 sitesin 6 countries
- Study dates
- Mar 2012to Jan 2013
- 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 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Russia8 sites
Novartis Investigative Site
Kemerovo, 650002
Novartis Investigative Site
Moscow, 121552
Novartis Investigative Site
Moscow, 127644
Novartis Investigative Site
S.-Petersburg, 198205
Novartis Investigative Site
Saint Petersburg, 192242
Novartis Investigative Site
Saint Petersburg, 198013
Novartis Investigative Site
Saint Petersburg, 199106
Novartis Investigative Site
Tomsk, 634012
Germany6 sites
Novartis Investigative Site
Bad Nauheim, 61231
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Dortmund, 44137
Novartis Investigative Site
Erfurt, 99089
Novartis Investigative Site
Greifswald, 17475
Novartis Investigative Site
Halle, 06120
Argentina2 sites
Novartis Investigative Site
Buenos Aires, Buenos Aires, B1846BMF
Novartis Investigative Site
Caba, Buenos Aires, C1180AAX
Poland2 sites
Novartis Investigative Site
Warsaw, 04-628
Novartis Investigative Site
Wroclaw, 50-981
About this study
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
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.
- Conditions
- Acute Heart Failure
- 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
Also called serelaxin*, *International Nonproprietary Name
Intravenous infusion of RLX030 over 20 hrs
PlaceboDrug
Intravenous infusion of placebo over 20 hours
| Study group | Role | What they receive |
|---|---|---|
| RLX030 | Experimental | RLX030 as intravenous infusion for 20 hours Receives: Drug: RLX030 |
| Placebo | Placebo comparator | Matching placebo as intravenous infusion for 20 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak change from baseline of PCWP (pulmonary capillary wedge pressure)
Measurements will be made using a Swan-Ganz indwelling catheter
Measured: baseline, after 8 and 20 hrs treatment
Peak change from baseline of CI (cardiac index)
Measurements will be made using a Swan-Ganz indwelling catheter
Measured: baseline, after 8 and 20 hrs treatment
Secondary outcomes (16)
Change over time of PCWP (pulmonary capillary wedge pressure)
Measurements will be made using a Swan-Ganz indwelling catheter
Measured: During 20 hours of infusion and up to 4 hours after stop of infusion
Change over time of systemic vascular resistance (SVR)
Measurements will be made using a Swan-Ganz indwelling catheter
Measured: During 20 hours of infusion and up to 4 hours after stop of infusion
Change over time of pulmonary vascular resistance (PVR)
Measurements will be made using a Swan-Ganz indwelling catheter
Measured: During 20 hours of infusion and up to 4 hours after stop of infusion
Change over time of pulmonary arterial pressure (PAP)
Hemodynamic measurements were made using a Swan-Ganz catheter when patients were in a supine position
Measured: During 20 hours of infusion and up to 4 hours after stop of infusion
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
Measured: During 20 hours of infusion and up to 4 hours after stop of infusion
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.
Measured: During 20 hours of infusion and 24 hours after stop of infusion
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.
Measured: During 20 hours of infusion and 24 hours after stop of infusion
Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h)
Blood will be collected from an in dwelling catheter.
Measured: During 20 hours of infusion and 24 hours after stop of infusion
Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)
Blood will be collected from an in dwelling catheter.
Measured: During 20 hours of infusion and 24 hours after stop of infusion
Pharmacokinetics of RLX030: mean residence time (MRT)
Blood will be collected from an in dwelling catheter.
Measured: During 20 hours of infusion and 24 hours after stop of infusion
Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration
Blood will be collected from an in dwelling catheter.
Measured: During 20 hours of infusion and 24 hours after stop of infusion
Change over time on calculated creatinine clearance
Urine samples will be collected for analyses.
Measured: During 20 hours of infusion and 4 hours after stop of infusion
Change over time in Diuresis
Urine samples will be collected for analyses.
Measured: During 20 hours of infusion and 4 hours after stop of infusion
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 20 hours of infusion and 24 hours after stop of infusion
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 20 hours of infusion and 24 hours after stop of infusion
Number of patients with adverse events, serious adverse events and death
Adverse events will be assessed by signs/symptoms, clinical laboratory and electrocardiographs.
Measured: During 20 hours of infusion and 24 hours after stop of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543854
- Sponsor's protocol ID
- CRLX030A2201
- Other IDs
- 2011-000833-35
- Status last verified
- Aug 2014
- First submitted
- 28 Feb 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
Publications
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.
PubMed 24255129
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01543854
- Acronym / sponsor ID
- CRLX030A2201
- Conditions
- Acute Heart Failure
- Keywords
- Heart failure, RLX030, Hemodynamics, Cardiovascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RLX030 | Experimental | Drug: RLX030RLX030 as intravenous infusion for 20 hours |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo as intravenous infusion for 20 hours. |
Who may qualify
- Ages
- 18 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RLX030Also: serelaxin*, *International Nonproprietary NameIntravenous infusion of RLX030 over 20 hrs | Drug | RLX030 |
| PlaceboIntravenous infusion of placebo over 20 hours | Drug | Placebo |
Primary outcome
Peak change from baseline of PCWP (pulmonary capillary wedge pressure)
Time frame: baseline, after 8 and 20 hrs treatment
Measurements will be made using a Swan-Ganz indwelling catheter
Peak change from baseline of CI (cardiac index)
Time frame: baseline, after 8 and 20 hrs treatment
Measurements will be made using a Swan-Ganz indwelling catheter
16 secondary outcomes
Change over time of PCWP (pulmonary capillary wedge pressure)
Time frame: During 20 hours of infusion and up to 4 hours after stop of infusion
Change over time of systemic vascular resistance (SVR)
Time frame: During 20 hours of infusion and up to 4 hours after stop of infusion
Change over time of pulmonary vascular resistance (PVR)
Time frame: During 20 hours of infusion and up to 4 hours after stop of infusion
Change over time of pulmonary arterial pressure (PAP)
Time frame: During 20 hours of infusion and up to 4 hours after stop of infusion
Change over time of pulmonary and peripheral oxygen saturation
Time frame: During 20 hours of infusion and up to 4 hours after stop of infusion
Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to infinity (AUCinf)
Time frame: During 20 hours of infusion and 24 hours after stop of infusion
Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: During 20 hours of infusion and 24 hours after stop of infusion
Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C20h)
Time frame: During 20 hours of infusion and 24 hours after stop of infusion
Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)
Time frame: During 20 hours of infusion and 24 hours after stop of infusion
Pharmacokinetics of RLX030: mean residence time (MRT)
Time frame: During 20 hours of infusion and 24 hours after stop of infusion
Pharmacokinetics of RLX030: volume of distribution at steady state following intravenous administration
Time frame: During 20 hours of infusion and 24 hours after stop of infusion
Change over time on calculated creatinine clearance
Time frame: During 20 hours of infusion and 4 hours after stop of infusion
Change over time in Diuresis
Time frame: During 20 hours of infusion and 4 hours after stop of infusion
Central aortic systolic pressure-time curve
Time frame: During 20 hours of infusion and 24 hours after stop of infusion
Radial augmentation index-time curve
Time frame: During 20 hours of infusion and 24 hours after stop of infusion
Number of patients with adverse events, serious adverse events and death
Time frame: During 20 hours of infusion and 24 hours after stop of infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Derived from this study: PubMed 24255129Ponikowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RLX030 in people with Acute Heart Failure, run by Novartis Pharmaceuticals at 20 sites in 6 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 2 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Russia, Germany, Argentina, Poland, Italy and 1 more country. 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?
Peak change from baseline of PCWP (pulmonary capillary wedge pressure) (time frame: baseline, after 8 and 20 hrs treatment). 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 NCT01543854, 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 5 Aug 2014.