4914 ATHENA-Study looking at how ziltivekimab works v placebo-people with heart failure/inflammation
Research type
Research Study
Full title
ATHENA: Effects of ziltivekimab versus placebo on heart failure symptoms and physical function in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation
IRAS ID
1008992
Contact name
Clinical Transparency
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2023-506988-34
Research summary
This study is being carried out to see if a new medicine, ziltivekimab , can be used to treat people living with heart failure and inflammation. Heart failure is a condition in which the heart muscle is unable to pump enough blood to meet the body's needs all the time. People living with heart failure often have inflammation. Inflammation is a critical process for wound healing and to fight off bacteria and viruses. Inflammation is crucial for our survival but sometimes inflammation can be bad for us. Inflammation that goes unchecked for a long time can cause the heart to stiffen and this leads to heart failure.
Currently, there is no medicine to manage such inflammation. Completed studies showed that ziltivekimab can lower inflammation. This may have a positive effect on overall health in everyday life by reducing physical limitations and strengthening heart function. The ATHENA study will look more into this effect.
The study is planned to be conducted in 18 countries with approximately 150 sites, 2,300 participants who will be randomly given either ziltivekimab or placebo (dummy drug). Both will be administered subcutaneously (injection under the skin) once a month and will be added to standard of care.The study duration is expected to be 16 months, the recruitment period is anticipated to be 12 months.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0390
Date of REC Opinion
24 Jan 2024
REC opinion
Further Information Favourable Opinion