Cardiomyopathy, DilatedPhase 2NCT01391507
Pilot Study of COR-1 in Heart Failure
A Phase 2 study testing 0.9 % sodium chloride, COR-1 and Standard therapy for heart failure in people with Cardiomyopathy, Dilated, run by Corimmun GmbH at 4 sites in Germany.
Trial summary
The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiomyopathy, Dilated
- What is being tested?
- 0.9 % sodium chloride, COR-1 and Standard therapy for heart failure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 4 sitesGermany
- Study dates
- Oct 2011to Aug 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed heart failure due to dilated cardiomyopathy with left ventricular ejection fraction < 45%
- Presence of anti-beta1-receptor autoantibodies
- New York Heart Association (NYHA) class II to III heart failure
- Symptomatic heart failure for >1 year and < 8 years
- Treatment with adequate doses of angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta-blockers, and optional aldosterone antagonists according to guidelines for at least six months (with the exception of lack of tolerability of any of these drugs) and at stable doses for 2 months prior to screening
Who cannot join
- Ischemic heart disease characterized by >= 50% coronary artery stenosis and/or history of myocardial infarction
- Third or higher degree valvular defect
- Any disease requiring immunosuppressive drugs (except for <= 5 mg/day prednisone-equivalent dose) or any clinically relevant disorder of the immune system
- History of severe allergies and increased risk for anaphylactic shock (e.g., bronchial asthma)
- History of, or currently active illness, considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Study site
München
Study site
Regensburg
Study site
Tübingen
Study site
Würzburg
About this study
Official title: COR-1, an Anti-Beta1 Receptor Antibody Cyclopeptide in Heart Failure: a Phase II, Multicentre, Randomised, Double-Blind and Placebo-Controlled Study With Parallel Groups
The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed.
Read the detailed description
In patients with dilated cardiomyopathy (heart is weakened and enlarged), the presence of anti-beta1-receptor autoantibodies has been shown to predict more depressed left ventricular function, increased prevalence of serious ventricular arrhythmias, sudden cardiac death, and cardiovascular mortality. In animal models, COR-1 cyclopeptide has been shown to bind to, and therefore decrease, the anti-beta1-receptor autoantibody titre. This study will investigate the safety and effectiveness of COR-1 treatment in patients with dilated cardiomyopathy. This study will be a randomized (the study treatment is assigned by chance), double-blind, (neither investigator nor patient knows the treatment that the volunteer receives), multicenter (study is conducted in more than one center) placebo-controlled (one of the treatments is inactive), parallel group study (patients in different treatment groups receive medication at the same time) in men and women who have heart failure due to dilated cardiomyopathy. Eligible patients should also have a left ventricular ejection fraction of less than or equal to 45% (measurement of the percentage of blood leaving the heart each time it contracts) and should be positive for anti-beta1-receptor autoantibodies. The study will consist of 3 phases: a screening phase, a double-blind treatment period, and a follow-up phase. Patients will be randomly assigned to 1 of 4 treatment groups: 20 mg COR-1, 80 mg COR-1, 160 mg COR-1, or placebo (inactive medication). Each patient will receive 1 intravenous dose (medication is injected into a vein) every 4 weeks for a total of 6 months. Patients will come to the study center each time they receive study medication and will remain at the center for 2 to 3 hours following the injection. Blood samples will be drawn at time points during the screening, treatment, and follow-up periods. Patients will return to the study center for follow-up visits at 3 months following completion of the 6-month treatment period. Patients will participate in the study for approximately 9 months. Patient safety will be monitored. The study drug (COR-1) is being investigated for the treatment of heart failure.
- Conditions
- Cardiomyopathy, Dilated
- Being tested
- 0.9 % sodium chloride, COR-1, Standard therapy for heart failure
- Keywords
- Anti-beta1-receptor autoantibodies, COR-1, Heart failure
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9 % sodium chlorideDrug
Monthly intravenous injection for 6 months
COR-1Drug
Monthly intravenous injection for 6 months
Standard therapy for heart failureDrug
All patients will continue to receive standard therapy for heart failure (ie, in accordance with guidelines) throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: 0.9 % sodium chloride; Drug: Standard therapy for heart failure |
| 20 mg COR-1 | Experimental | Not described Receives: Drug: COR-1; Drug: Standard therapy for heart failure |
| 80 mg COR-1 | Experimental | Not described Receives: Drug: COR-1; Drug: Standard therapy for heart failure |
| 160 mg COR-1 | Experimental | Not described Receives: Drug: COR-1; Drug: Standard therapy for heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6
The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).
Measured: Baseline and Month 6
Secondary outcomes (9)
Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9
The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (local assessment).
Measured: Baseline and Month 9
Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6
The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events.
Measured: Baseline and Month 6
Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6
Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons.
Measured: Baseline and Month 6
Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6
Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons.
Measured: Baseline and Month 6
Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6
A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured.
Measured: Baseline and Month 6
Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression
Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances [20-100 m]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants).
Measured: Baseline and Month 6
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6
Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant's perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL.
Measured: Baseline and Month 6
Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated.
Measured: Baseline and Month 6
Number of Participants With Holter Electrocardiography (ECG) Parameters
A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2013
- Study completionAug 2013
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiomyopathy, DilatedStudies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corimmun GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corimmun GmbH Clinical Trial, Study director, Corimmun GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391507
- Sponsor's protocol ID
- CR100913
- Other IDs
- 2010-022579-68, COR-1/02
- Status last verified
- Oct 2014
- First submitted
- 4 Jul 2011
- Last updated
- 17 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jahns R, Boivin V, Siegmund C, Inselmann G, Lohse MJ, Boege F. Autoantibodies activating human beta1-adrenergic receptors are associated with reduced cardiac function in chronic heart failure. Circulation. 1999 Feb 9;99(5):649-54. doi: 10.1161/01.cir.99.5.649.
PubMed 9950662Stork S, Boivin V, Horf R, Hein L, Lohse MJ, Angermann CE, Jahns R. Stimulating autoantibodies directed against the cardiac beta1-adrenergic receptor predict increased mortality in idiopathic cardiomyopathy. Am Heart J. 2006 Oct;152(4):697-704. doi: 10.1016/j.ahj.2006.05.004.
PubMed 16996841Iwata M, Yoshikawa T, Baba A, Anzai T, Mitamura H, Ogawa S. Autoantibodies against the second extracellular loop of beta1-adrenergic receptors predict ventricular tachycardia and sudden death in patients with idiopathic dilated cardiomyopathy. J Am Coll Cardiol. 2001 Feb;37(2):418-24. doi: 10.1016/s0735-1097(00)01109-8.
PubMed 11216956Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):480-6. doi: 10.1161/CIRCULATIONAHA.108.191259. No abstract available.
PubMed 19171871
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COR-1, an Anti-Beta1 Receptor Antibody Cyclopeptide in Heart Failure: a Phase II, Multicentre, Randomised, Double-Blind and Placebo-Controlled Study With Parallel Groups
- ClinicalTrials.gov ID
- NCT01391507
- Acronym / sponsor ID
- CR100913
- Conditions
- Cardiomyopathy, Dilated
- Keywords
- Anti-beta1-receptor autoantibodies, COR-1, Heart failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Corimmun GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Posted 26 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed.
Detailed description
In patients with dilated cardiomyopathy (heart is weakened and enlarged), the presence of anti-beta1-receptor autoantibodies has been shown to predict more depressed left ventricular function, increased prevalence of serious ventricular arrhythmias, sudden cardiac death, and cardiovascular mortality. In animal models, COR-1 cyclopeptide has been shown to bind to, and therefore decrease, the anti-beta1-receptor autoantibody titre. This study will investigate the safety and effectiveness of COR-1 treatment in patients with dilated cardiomyopathy. This study will be a randomized (the study treatment is assigned by chance), double-blind, (neither investigator nor patient knows the treatment that the volunteer receives), multicenter (study is conducted in more than one center) placebo-controlled (one of the treatments is inactive), parallel group study (patients in different treatment groups receive medication at the same time) in men and women who have heart failure due to dilated cardiomyopathy. Eligible patients should also have a left ventricular ejection fraction of less than or equal to 45% (measurement of the percentage of blood leaving the heart each time it contracts) and should be positive for anti-beta1-receptor autoantibodies. The study will consist of 3 phases: a screening phase, a double-blind treatment period, and a follow-up phase. Patients will be randomly assigned to 1 of 4 treatment groups: 20 mg COR-1, 80 mg COR-1, 160 mg COR-1, or placebo (inactive medication). Each patient will receive 1 intravenous dose (medication is injected into a vein) every 4 weeks for a total of 6 months. Patients will come to the study center each time they receive study medication and will remain at the center for 2 to 3 hours following the injection. Blood samples will be drawn at time points during the screening, treatment, and follow-up periods. Patients will return to the study center for follow-up visits at 3 months following completion of the 6-month treatment period. Patients will participate in the study for approximately 9 months. Patient safety will be monitored. The study drug (COR-1) is being investigated for the treatment of heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9 % sodium chloride, Drug: Standard therapy for heart failure |
| 20 mg COR-1 | Experimental | Drug: COR-1, Drug: Standard therapy for heart failure |
| 80 mg COR-1 | Experimental | Drug: COR-1, Drug: Standard therapy for heart failure |
| 160 mg COR-1 | Experimental | Drug: COR-1, Drug: Standard therapy for heart failure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed heart failure due to dilated cardiomyopathy with left ventricular ejection fraction < 45%
- Presence of anti-beta1-receptor autoantibodies
- New York Heart Association (NYHA) class II to III heart failure
- Symptomatic heart failure for >1 year and < 8 years
- Treatment with adequate doses of angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta-blockers, and optional aldosterone antagonists according to guidelines for at least six months (with the exception of lack of tolerability of any of these drugs) and at stable doses for 2 months prior to screening
Key exclusion criteria (5 listed)
- Ischemic heart disease characterized by >= 50% coronary artery stenosis and/or history of myocardial infarction
- Third or higher degree valvular defect
- Any disease requiring immunosuppressive drugs (except for <= 5 mg/day prednisone-equivalent dose) or any clinically relevant disorder of the immune system
- History of severe allergies and increased risk for anaphylactic shock (e.g., bronchial asthma)
- History of, or currently active illness, considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
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 |
|---|---|---|
| 0.9 % sodium chlorideMonthly intravenous injection for 6 months | Drug | Placebo |
| COR-1Monthly intravenous injection for 6 months | Drug | 160 mg COR-1, 20 mg COR-1, 80 mg COR-1 |
| Standard therapy for heart failureAll patients will continue to receive standard therapy for heart failure (ie, in accordance with guidelines) throughout the study. | Drug | 160 mg COR-1, 20 mg COR-1, 80 mg COR-1, Placebo |
Primary outcome
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6
Time frame: Baseline and Month 6
The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).
9 secondary outcomes
Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9
Time frame: Baseline and Month 9
Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6
Time frame: Baseline and Month 6
Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression
Time frame: Baseline and Month 6
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
Time frame: Baseline and Month 6
Number of Participants With Holter Electrocardiography (ECG) Parameters
Time frame: Baseline and Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9950662Jahns R, Boivin V, Siegmund C, Inselmann G, Lohse MJ, Boege F. Autoantibodies activating human beta1-adrenergic receptors are associated with reduced cardiac function in chronic heart failure. Circulation. 1999 Feb 9;99(5):649-54. doi: 10.1161/01.cir.99.5.649.
- Background: PubMed 16996841Stork S, Boivin V, Horf R, Hein L, Lohse MJ, Angermann CE, Jahns R. Stimulating autoantibodies directed against the cardiac beta1-adrenergic receptor predict increased mortality in idiopathic cardiomyopathy. Am Heart J. 2006 Oct;152(4):697-704. doi: 10.1016/j.ahj.2006.05.004.
- Background: PubMed 11216956Iwata M, Yoshikawa T, Baba A, Anzai T, Mitamura H, Ogawa S. Autoantibodies against the second extracellular loop of beta1-adrenergic receptors predict ventricular tachycardia and sudden death in patients with idiopathic dilated cardiomyopathy. J Am Coll Cardiol. 2001 Feb;37(2):418-24. doi: 10.1016/s0735-1097(00)01109-8.
- Background: PubMed 19171871Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):480-6. doi: 10.1161/CIRCULATIONAHA.108.191259. No abstract available.
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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.
Corimmun GmbH Clinical Trial study director
Corimmun GmbH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.9 % sodium chloride, COR-1 and Standard therapy for heart failure in people with Cardiomyopathy, Dilated, run by Corimmun GmbH at 4 sites in Germany.
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 5 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: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2014). 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?
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 (time frame: Baseline and Month 6). 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 NCT01391507, which also lists 4 linked publications.
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 17 Oct 2014.