Heart Failure With Reduced Ejection FractionPhase 4COREVIVE-HFrEFNCT05971732
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
A Phase 4 study testing Ferric derisomaltose in people with Heart Failure With Reduced Ejection Fraction and Iron Deficiency, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Iron Deficiency, Acute Heart Failure
- What is being tested?
- Ferric derisomaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years.
- Clinical diagnosis of heart failure with reduced ejection fraction (HFrEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) <50% before randomization.
- Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation, New York Heart Association (NYHA) class II - IV.
- Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:
- Systolic blood pressure≥100mmHg, without symptoms of hypotension;
- Stop using intravenous diuretics;
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- Neither intravenous inotropic drugs or vasodilators were used (including nitrates).
- Subject is iron deficient defined as serum ferritin <100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT <20%.
- Able and willing to provide informed consent and accomplish 6 minutes-walking test.
Who cannot join
- Hematological criteria: ferritin >400 ug/L; hemoglobin <9.0, hemoglobin >13.5 g/dL in women or >14.5 g/dL in men.
- Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) <15ml/min/1.73m2
- Body weight <35kg at randomization.
- Heart failure was secondary to valvular diseases or congenital heart diseases.
- History of acquired iron overload or hemochromatosis (or first-degree relative of hemochromatosis)
- Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)).
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- Non-iron deficiency anaemia.
- Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in previous 4 weeks prior to randomization.
- Active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal haemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease) and history of malignant tumor.
- Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate> 100 beats / min at rest).
- Known positive HBsAg and/or HCV RNA; known HIV positivity; chronic liver disease (including active hepatitis), hepatic sclerosis, ALT or AST > 3x upper limit of normal.
- Within 3 months of any of the following: acute myocardial infarction (AMI) or acute coronary syndrome (ACS), transient ischemic attack (TIA) or stroke, uncontrolled hypertension.
- Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) in the past 3 months; or planning cardiac surgery or revascularization.
- Baseline 6 minutes-walking distance>500m.
- Treated with long-term oral high-dose or steroid-immunosuppression therapy.
- Investigator considers a possible alternative diagnosis to explain the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD).
- Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
- Untreated hypothyroidism.
- Currently enrolled in any other investigational device or drug study <30 days prior to screening, or received other investigational agent(s).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Ying Zhou, MD, +86-13699164283, 929352903@qq.com
About this study
Official title: The Effects of Ferric Derisomaltose Administered Before Hospital Discharge in Stabilised Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life: a Randomised, Parallel-group, Double-blind, Placebo Controlled Trial (COREVIVE-HFrEF)
This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.
Read the detailed description
Acute heart failure (AHF) is a very common medical problem. Despite improvements in treatment, many patients suffer limiting exercise capacity and quality of life. Previous comorbidities may account for it. Approximately 80% of patients hospitalized with AHF suffered from a combination of iron deficiency. A decline in exercise capacity may occur under this condition. Some research studies have suggested that giving CHF patients intravenous iron improves symptoms in the short term. It is unknown, however, whether correcting iron deficiency is beneficial to patients with AHF to improve excise capacity and whether it improves quality of life and accelerate recovery from acute duration. This study will help us answer these key questions.
This is an investigator-initiated, randomised, parallel group, double-blind, placebo-controlled trial, evaluating the excise capacity improvement of using ferric derisomaltose versus placebo in hospitalized patients with acute heart failure with reduced ejection fraction before discharge.
Participants will be assessed daily using 6-minute walking test after IV iron injection until discharge from hospital, especially focus on the change from baseline to the 3rd day. Some questionnaires are also conducted to evaluate the self-reported status. Participants will be followed up at 2 weeks and 4 weeks.
The primary and secondary endpoints will be examined in subgroups predefined by baseline variables reflecting demography, Hb level, etiology of HF, left ventricular ejection fraction, natriuretic peptide, index of iron metabolism, eGFR and others.
- Being tested
- Ferric derisomaltose, Placebo
- Keywords
- Exercise capacity, Quality of life, Acute Heart Failure
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric derisomaltoseDrug
Also called Monofer, Iron (III) isomaltoside 1000
After baseline assessments patients will be randomised in a 1:1 ratio to receive ferric derisomaltose IV or placebo (normal saline). In the Treatment group, Ferric derisomaltose will be administered according to the dosing schedule.
PlaceboDrug
Also called Normal saline
In the placebo group, patients will receive the equivalent number of normal saline injections.
| Study group | Role | What they receive |
|---|---|---|
| Ferric derisomaltose | Experimental | Iron to be administered as ferric derisomaltose.
The treatment dose (mL) to be administered will be determined by the patient's body weight and hemoglobin (Hb) value.
Where Hb ≥10 g/dL, dosage according to body weight is as follows:
Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 1000 mg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 1500 mg.
Where Hb <10 g/dL, dosage according to body weight is as follows:
Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 20 mg/kg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 2000 mg.
Infused over a minimum of 15mins for doses up to and including 1000mg, and a minimum of 30 mins for doses >1000mg Receives: Drug: Ferric derisomaltose |
| Placebo | Placebo comparator | Participants in this arm will receive normal saline 0.9% in analogy to treatment arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute walking distance
The difference of 6-minute walking distance in meters from baseline to day3 after IV iron injection.
Measured: Up to 3 days
Secondary outcomes (13)
Change From Baseline in 6-minute walking distance
The difference of 6-minute walking distance in meters from baseline at 2 weeks, 4weeks after IV iron injection.
Measured: At 2 weeks, 4weeks after IV iron injection
Change From Baseline in the KCCQ Clinical Summary Score
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Measured: At 2 weeks, 4weeks after IV iron injection
Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value
EQ-5D-5L: European Quality of Life-5 Dimensions-5 Levels The EQ 5D questionnaire consists of a health descriptive system for participants to self-classify and rate their health status on the day of administration.
The descriptive system includes 5 items/dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are coded from 1 (best state) to 5 (worst state).
Measured: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in NYHA Functional Class
NYHA = New York Heart Association
NYHA functional class was assessed as Class I, II, III, IV:
Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest.
Lower response categories are better for score NYHA.
Measured: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in PGA quality of life questionnaire
PGA:Patient Global Assessment
PGA questionnaire consists of a health descriptive system for participants to self-reported and rate their medical condition after participate this study.
The descriptive system includes 7 choices：has much improved, has (moderately) improved, has a little improved, is unchanged, is a little worse, is (moderately) worse, is much worse, which are coded from 1 (best state) to 7 (worst state).
Measured: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Concentration of hemoglobin (Hb)
Hemoglobin (Hb) is a commonly used clinical test for assessing anaemia, with units of g/L.
Measured: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in proportion of reticulocyte (Ret%)
The reticulocyte ratio is often used to reflect the hematopoiesis of the bone marrow erythrocyte with units of percentage(%).
Measured: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Concentration of ferritin
To assess the effect of ferric derisomaltose vs. placebo on change in ferritin from baseline to 3 days, 2weeks and 4weeks
Measured: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in concentration of transferrin saturation
To assess the effect of ferric derisomaltose vs. placebo on change in transferrin saturation from baseline to 3 days, 2weeks and 4weeks
Measured: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Concentration of serum transferrin receptors (sTfR)
To assess the effect of ferric derisomaltose vs. placebo on change in serum transferrin receptors (sTfR) from baseline to 3 days, 2weeks and 4weeks
Measured: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
To assess the effect of ferric derisomaltose vs. placebo on change in NT-proBNP from baseline to 3 days, 2weeks and 4weeks
Measured: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Left Ventricular Systolic Function
Left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography.
Measured: At 2weeks, 4weeks after IV iron injection
Change From Baseline in Left Ventricular End-Diastolic Diameter
Left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Measured: At 2weeks, 4weeks after IV iron injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ren, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971732
- Sponsor's protocol ID
- Monofer-HFrEF
- Acronym
- COREVIVE-HFrEF
- Status last verified
- Nov 2026
- First submitted
- 13 Jul 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ferric Derisomaltose Administered Before Hospital Discharge in Stabilised Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life: a Randomised, Parallel-group, Double-blind, Placebo Controlled Trial (COREVIVE-HFrEF)
- ClinicalTrials.gov ID
- NCT05971732
- Acronym / sponsor ID
- COREVIVE-HFrEF / Monofer-HFrEF
- Keywords
- Exercise capacity, Quality of life, Acute Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Aug 2023 (actual)
- 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 address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.
Detailed description
Acute heart failure (AHF) is a very common medical problem. Despite improvements in treatment, many patients suffer limiting exercise capacity and quality of life. Previous comorbidities may account for it. Approximately 80% of patients hospitalized with AHF suffered from a combination of iron deficiency. A decline in exercise capacity may occur under this condition. Some research studies have suggested that giving CHF patients intravenous iron improves symptoms in the short term. It is unknown, however, whether correcting iron deficiency is beneficial to patients with AHF to improve excise capacity and whether it improves quality of life and accelerate recovery from acute duration. This study will help us answer these key questions.
This is an investigator-initiated, randomised, parallel group, double-blind, placebo-controlled trial, evaluating the excise capacity improvement of using ferric derisomaltose versus placebo in hospitalized patients with acute heart failure with reduced ejection fraction before discharge.
Participants will be assessed daily using 6-minute walking test after IV iron injection until discharge from hospital, especially focus on the change from baseline to the 3rd day. Some questionnaires are also conducted to evaluate the self-reported status. Participants will be followed up at 2 weeks and 4 weeks.
The primary and secondary endpoints will be examined in subgroups predefined by baseline variables reflecting demography, Hb level, etiology of HF, left ventricular ejection fraction, natriuretic peptide, index of iron metabolism, eGFR and others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric derisomaltose | Experimental | Drug: Ferric derisomaltoseIron to be administered as ferric derisomaltose. The treatment dose (mL) to be administered will be determined by the patient's body weight and hemoglobin (Hb) value. Where Hb ≥10 g/dL, dosage according to body weight is as follows: Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 1000 mg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 1500 mg. Where Hb <10 g/dL, dosage according to body weight is as follows: Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 20 mg/kg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 2000 mg. Infused over a minimum of 15mins for doses up to and including 1000mg, and a minimum of 30 mins for doses >1000mg |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will receive normal saline 0.9% in analogy to treatment arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years.
- Clinical diagnosis of heart failure with reduced ejection fraction (HFrEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) <50% before randomization.
- Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation, New York Heart Association (NYHA) class II - IV.
- Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:
- Subject is iron deficient defined as serum ferritin <100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT <20%.
Key exclusion criteria (19 listed)
- Hematological criteria: ferritin >400 ug/L; hemoglobin <9.0, hemoglobin >13.5 g/dL in women or >14.5 g/dL in men.
- Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) <15ml/min/1.73m2
- Body weight <35kg at randomization.
- Heart failure was secondary to valvular diseases or congenital heart diseases.
- History of acquired iron overload or hemochromatosis (or first-degree relative of hemochromatosis)
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 |
|---|---|---|
| Ferric derisomaltoseAlso: Monofer, Iron (III) isomaltoside 1000After baseline assessments patients will be randomised in a 1:1 ratio to receive ferric derisomaltose IV or placebo (normal saline). In the Treatment group, Ferric derisomaltose will be administered according to the dosing schedule. | Drug | Ferric derisomaltose |
| PlaceboAlso: Normal salineIn the placebo group, patients will receive the equivalent number of normal saline injections. | Drug | Placebo |
Primary outcome
Change in 6-minute walking distance
Time frame: Up to 3 days
The difference of 6-minute walking distance in meters from baseline to day3 after IV iron injection.
13 secondary outcomes
Change From Baseline in 6-minute walking distance
Time frame: At 2 weeks, 4weeks after IV iron injection
Change From Baseline in the KCCQ Clinical Summary Score
Time frame: At 2 weeks, 4weeks after IV iron injection
Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value
Time frame: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in NYHA Functional Class
Time frame: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in PGA quality of life questionnaire
Time frame: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Concentration of hemoglobin (Hb)
Time frame: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in proportion of reticulocyte (Ret%)
Time frame: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Concentration of ferritin
Time frame: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in concentration of transferrin saturation
Time frame: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Concentration of serum transferrin receptors (sTfR)
Time frame: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Time frame: At 3 days, 2weeks, 4weeks after IV iron injection
Change From Baseline in Left Ventricular Systolic Function
Time frame: At 2weeks, 4weeks after IV iron injection
Change From Baseline in Left Ventricular End-Diastolic Diameter
Time frame: At 2weeks, 4weeks after IV iron injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric derisomaltose in people with Heart Failure With Reduced Ejection Fraction and Iron Deficiency, run by China-Japan Friendship Hospital at 1 site in China.
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 19 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhou, Dr (+86-13699164283, 929352903@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walking distance (time frame: Up to 3 days). 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 6 Nov 2026.