HERMES: ziltivekimab in patients with HFmrEF or HFpEF and systemic inflammation
Research type
Research Study
Full title
HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.
IRAS ID
1006925
Contact name
Clinical Transparency
Contact email
Sponsor organisation
Novo Nordisk A/S
Clinicaltrials.gov Identifier
Research summary
We are doing this study to see if the 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 to our survival, but sometimes inflammation can be bad for us. Inflammation that goes unchecked for a long time can cause the heart tissue to stiffen. This may lead to heart failure. At the moment no medicine exists to manage such inflammation. Completed studies showed that ziltivekimab can lower inflammation, which may have a positive effect on heart failure symptoms and this study will look into this further.
This study is planned to be conducted in 46 countries, with approximately 720 sites. 5,600 participants will be randomly given either ziltivekimab or placebo (a dummy drug), both will be administered subcutaneously (injection under the skin) once a month and will be added to standard of care.
The study is event driven, therefore, the end of the study will be scheduled depending on the accumulated number of major adverse cardiovascular events (MACE). The study duration is expected to be up to 48 months (4 years) following randomisation of the first participant. The recruitment period is anticipated to be approximately 36 months. The total study duration for an individual participant is
estimated to be approximately 2.5 to 4 years, depending on the participant's date of entry in the study.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0004
Date of REC Opinion
31 Jul 2023
REC opinion
Further Information Favourable Opinion