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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501939-16-00
Acronym
EX6018-4915
Enrollment
2219
Registered
2023-05-01
Start date
2023-05-09
Completion date
Unknown
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure (HF) with mildly reduced ejection fraction (HFmrEF) or HF with preserved ejection fraction (HFpEF) and systemic inflammation.

Brief summary

Time to first occurrence of a composite HF endpoint consisting of CV death, HF hospitalisation or urgent HF visit from randomisation to end of study., Number of CV deaths, HF hospitalisations or urgent HF visits (first and recurrent) from randomisation to end of study.

Detailed description

Time to first occurrence of 4-point expanded composite HF endpoint, a composite endpoint consisting of CV death, HF hospitalisation or urgent HF visit, Non-fatal MI and Non-fatal stroke. Measued from randomisation to end of study, Time to first occurrence of 4-point expanded composite HF endpoint, a composite endpoint consisting of all-cause death, HF hospitalisation or urgent HF visit, Non-fatal MI and Non-fatal stroke. Measued from randomisation to end of study, Time to occurrence of CV death from randomisation to end of study, Time to occurrence of all-cause death from randomisation to end of study, Hierarchical composite of Time to all-cause death, number of HF hospitalisation or urgent HF visits, time to first HF hospitalisation or urgent HF visit (measured from randomisation to end of study) and difference of at least 5 in KCCQ clinical summary score change from baseline to 12 months (assessed by the win ratio), Time to first occurrence of HF hospitalisation or urgent HF visit from randomisation to end of study, Number of events of atrial fibrillation from randomisation to end of study, Change in KCCQ clinical summary score from randomisation to 12 months, Improvement of 5 points or more in KCCQ clinical summary score (yes/no) ) from randomisation to 12 months, Improvement of 10 points or more in KCCQ clinical summary score (yes/no) from randomisation to 12 months, Improvement in NYHA Class (yes/no) from randomisation to 12 months, Time to first occurrence of a composite CKD endpoint consisting of CV death, onset of persistent ≥ 40% reduction in eGFR (CKD-EPI) compared with baseline and kidney failure (defined as death from kidney failure, onset of persistent eGFR< 15 mL/min/1.73 m^2 (CKD-EPI), initiation of chronic kidney replacement therapy (maintenance dialysis or kidney transplantation). Measured from randomisation to end of study, Change in eGFR (CKD-EPI) from randomisation to 12 months, Annual rate of change in eGFR (CKD-EPI) (total eGFR slope) from randomisation to end of study, Number of hospitalisations with infection as primary cause or death due to infection. Measured from randomisation to end of study, Change in hs-CRP from randomisation to 12 months, Change in NT-proBNP from randomisation to 12 months, Change in CCI from randomisation to 12 months, Participants achieving threshold of meaningful within-patient change (MWPC) in KCCQ-CSS (yes/no) from randomisation to 12 months

Interventions

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to first occurrence of a composite HF endpoint consisting of CV death, HF hospitalisation or urgent HF visit from randomisation to end of study., Number of CV deaths, HF hospitalisations or urgent HF visits (first and recurrent) from randomisation to end of study.

Secondary

MeasureTime frame
Time to first occurrence of 4-point expanded composite HF endpoint, a composite endpoint consisting of CV death, HF hospitalisation or urgent HF visit, Non-fatal MI and Non-fatal stroke. Measued from randomisation to end of study, Time to first occurrence of 4-point expanded composite HF endpoint, a composite endpoint consisting of all-cause death, HF hospitalisation or urgent HF visit, Non-fatal MI and Non-fatal stroke. Measued from randomisation to end of study, Time to occurrence of CV death from randomisation to end of study, Time to occurrence of all-cause death from randomisation to end of study, Hierarchical composite of Time to all-cause death, number of HF hospitalisation or urgent HF visits, time to first HF hospitalisation or urgent HF visit (measured from randomisation to end of study) and difference of at least 5 in KCCQ clinical summary score change from baseline to 12 months (assessed by the win ratio), Time to first occurrence of HF hospitalisation or urgent HF visit fr

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026