At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ziltivekimab (drug), Placebo (drug)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- Ziltivekimab — drug: Ziltivekimab subcutaneous (s.c.) injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years. · Placebo — drug: Ziltivekimab placebo s.c.
- Patient visit burden
- "Participants will have up to 20 clinic visits." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 4,874
- Started
- 2023-05-08
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure
- • Phase3 - 4,874 participants
- • This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with heart failure
Where?
- • Bournemouth - Royal Bournemouth Hospital
- • Basildon - Basildon University Hospital
- • Airdrie - University Hospital Monklands - Cardiology Research
- • Tooting - St George's Hospital - Cardiology
- • +18 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ intravenous loop diuretic treatment, within the last 9 months
What the study is looking for
- ✓Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg/L) at screening...
- ✓At least one of the following:
- ✓Diagnosis of heart failure (New York Heart Association \[classification\] \[NYHA\] Class II-IV).
- ✓Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or...
- ✓Left atrial (LA) volume index greater than 34 milliliters per meter square (mL/m\^2).
Who cannot take part
- ✗Medical conditions - cardiovascular
- ✗Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure...
- ✗Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note:...
- ✗Planned heart device or atrial flutter/atrial fibrillation ablation procedure known during the screening period...
- ✗Primary lung hypertension, chronic lung embolism, severe lung disease including COPD.
See the full criteria
Where Is This Study? (22 UK sites)
Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200Basildon University Hospital
Basildon SS16 5NL, United Kingdom
University Hospital Monklands - Cardiology Research
Airdrie ML6 0JS, United Kingdom
St George's Hospital - Cardiology
Tooting SW17 0RE, United Kingdom
St George's Hospital
Tooting SW17 0RE, United Kingdom
University Hospital Hairmyres - Cardiology
East Kilbride G75 8RG, United Kingdom
St. Richard's Hospital_Cardiology
Chichester PO19 6SE, United Kingdom
St. Richards Hospital
Chichester PO19 6SE, United Kingdom
Aberdeen Royal Infirmary
Aberdeen AB25 2ZN, United Kingdom
Southmead Hospital
Bristol BS10 5NB, United Kingdom
Craigavon Area Hospital - Cardiovascular Research Unit
Craigavon BT63 5QQ, United Kingdom
Royal Bournemouth Hospital
Dorest BH7 7DW, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200Royal Devon and Exeter Hospital
Exeter EX2 5DW, United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Exeter EX2 5DW, United Kingdom
Glasgow Royal Infirmary
Glasgow G31 2ER, United Kingdom
Wycombe General Hospital
High Wycombe HP11 2TT, United Kingdom
Aintree University Hospital
Liverpool L9 7AL, United Kingdom
Manchester Royal Infirmary - Manchester Heart Centre
Manchester M13 9WL, United Kingdom
North Tyneside General Hospital
North Shields NE29 8NH, United Kingdom
Research and Development
researchanddevelopment@nhct.nhs.uk0191 2934087The Royal Oldham Hospital_Cardiology Outpatients Dept.
Oldham OL1 2JH, United Kingdom
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
University of North Tees Hospital
Stockton-on-Tees TS19 8PE, United Kingdom
Research and Development
nth-tr.ntandh.researchdevelopment@nhs.net01642 624090