Chronic Heart FailurePhase 2RELAX-CardioNCT02625922
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
A Phase 2 study testing Serelaxin in people with Chronic Heart Failure, run by Novartis Pharmaceuticals at 9 sites in 3 countries.
Trial summary
This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Serelaxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 5 Feb 2016to 11 Jan 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female ≥ 18 years of age, with body weight ≤ 160 Kg
- Diagnosis of stable CHF:
- New York Heart Association (NYHA) functional Class II/III.
- Receiving guideline-recommended treatment for CHF.
- Left ventricular ejection fraction < 45%, obtained within the last 3 months prior to screening.
- NT-proBNP > 300 ng/L in sinus rhythm or > 900 ng/L if not in sinus rhythm (determined locally).
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- Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.
- Systolic BP ≥ 125 mmHg at randomization
- Renal function defined as an eGFR of ≥ 25 mL/min/1.73 m^2 at screening (sMDRD formula).
Who cannot join
- Dyspnea primarily due to non-cardiac causes.
- Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.
- Any contraindication for exercise testing and spirometry.
- Stopping of the spiroergometry at screening according to the stopping rules, unless the patient has reached maximum exercise capacity defined as carbon dioxide production/oxygen consumption (VCO2/VO2) > 1.05.
- Change in guideline-recommended CHF treatment within 1 month prior to screening.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Germany5 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Greifswald, Mecklenburg-Vorpommern, 17475
Novartis Investigative Site
München, 80636
Novartis Investigative Site
München, 81675
United Kingdom3 sites
Novartis Investigative Site
Hull, HU16 5JQ
Novartis Investigative Site
London, SW 6NP
Novartis Investigative Site
Tyne and Wear, NE2 4HH
About this study
Official title: A Multicenter, Randomized, Double-blind, Crossover Placebo-controlled Phase II Study to Assess the Effect of Serelaxin Versus Placebo on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure After Exercise When Used in Addition to Standard of Care
This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.
- Conditions
- Chronic Heart Failure
- Being tested
- Serelaxin, Placebo
- Keywords
- Serelaxin,, Chronic heart failure,, Spiroergometry,, Troponin,, New York Heart Association (NYHA) functional Class II/III,, Left ventricular ejection fraction,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerelaxinDrug
Also called RLX030
Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen
PlaceboDrug
Matching placebo i.v infusion
| Study group | Role | What they receive |
|---|---|---|
| Serelaxin followed by Placebo | Experimental | On Day 1 of treatment period 1, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Receives: Drug: Serelaxin; Drug: Placebo |
| Placebo followed by Serelaxin | Experimental | On Day 1 of treatment period 1, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Receives: Drug: Serelaxin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Measured: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1)
Secondary outcomes (3)
Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Measured: 4 and 5 hours after exercise testing session
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Measured: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Measured: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start5 Feb 2016
- Primary completion11 Jan 2017
- Study completion11 Jan 2017
Why it stopped: In view of outcome of RELAX-AHF-2 trial, the entire RLX030A project was decided to be terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 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
- NCT02625922
- Sponsor's protocol ID
- CRLX030A2211
- Other IDs
- 2015-002673-38, 2015
- Acronym
- RELAX-Cardio
- Status last verified
- Jan 2018
- First submitted
- 3 Dec 2015
- Last updated
- 21 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Crossover Placebo-controlled Phase II Study to Assess the Effect of Serelaxin Versus Placebo on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure After Exercise When Used in Addition to Standard of Care
- ClinicalTrials.gov ID
- NCT02625922
- Acronym / sponsor ID
- RELAX-Cardio / CRLX030A2211
- Conditions
- Chronic Heart Failure
- Keywords
- Serelaxin,, Chronic heart failure,, Spiroergometry,, Troponin,, New York Heart Association (NYHA) functional Class II/III,, Left ventricular ejection fraction,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In view of outcome of RELAX-AHF-2 trial, the entire RLX030A project was decided to be terminated.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2016
- Primary completion
- 11 Jan 2017 (actual)
- Study completion
- 11 Jan 2017 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Posted 21 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serelaxin followed by Placebo | Experimental | Drug: Serelaxin, Drug: PlaceboOn Day 1 of treatment period 1, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. |
| Placebo followed by Serelaxin | Experimental | Drug: Serelaxin, Drug: PlaceboOn Day 1 of treatment period 1, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥ 18 years of age, with body weight ≤ 160 Kg
- Diagnosis of stable CHF:
- Left ventricular ejection fraction < 45%, obtained within the last 3 months prior to screening.
- NT-proBNP > 300 ng/L in sinus rhythm or > 900 ng/L if not in sinus rhythm (determined locally).
- Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.
Key exclusion criteria (5 listed)
- Dyspnea primarily due to non-cardiac causes.
- Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.
- Any contraindication for exercise testing and spirometry.
- Stopping of the spiroergometry at screening according to the stopping rules, unless the patient has reached maximum exercise capacity defined as carbon dioxide production/oxygen consumption (VCO2/VO2) > 1.05.
- Change in guideline-recommended CHF treatment within 1 month prior to screening.
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 |
|---|---|---|
| SerelaxinAlso: RLX030Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen | Drug | Placebo followed by Serelaxin, Serelaxin followed by Placebo |
| PlaceboMatching placebo i.v infusion | Drug | Placebo followed by Serelaxin, Serelaxin followed by Placebo |
Primary outcome
Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo
Time frame: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1)
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
3 secondary outcomes
Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours
Time frame: 4 and 5 hours after exercise testing session
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
Time frame: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
Time frame: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serelaxin in people with Chronic Heart Failure, run by Novartis Pharmaceuticals at 9 sites in 3 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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, United Kingdom, Switzerland. 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. 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?
Yes. Results are posted in the registry (first posted 21 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo (time frame: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2018.