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

Heart failure with mildly reduced or preserved ejection fraction and systemic inflammation

Primary: Change in KCCQ clinical summary score (KCCQ-CSS) from randomisation (month 0) to end-of-treatment (month 12) (Score (score on scale; range; 0-100))

Confirmatory secondary: Change in six-minute walk distance (6MWD) from randomisation (month 0) to end-of-treatment (month 12) (Metres), Supportive secondary: Change in hs-CRP from randomisation (month 0) to end-of-treatment (month 12) (Ratio to baseline), Supportive secondary: Participants experiencing improvement in NYHA Class (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participant), Supportive secondary: Change in NT-proBNP from randomisation (month 0) to end-of-treatment (month 12) (Ratio to baseline), Supportive secondary: Change in eGFR (CKD-EPI) from randomisation (month 0) to end-of-treatment (month 12) (mL/min/1.73 m2), Supportive secondary: Participants achieving threshold for meaningful within- patient change in KCCQ-CSS (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants), Supportive secondary: Participants achieving threshold for meaningful within- patient change in 6MWD (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants), Supportive secondary: Participants improving 5 points or more in KCCQ-CSS (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants), Supportive secondary: Participants improving 10 points or more in KCCQ-CSS (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants), Supportive secondary: Change in KCCQ overall summary score (KCCQ-CCS) from randomisation (month 0) to end-of-treatment (month 12) (Score (score on scale; range 0-100)), Supportive secondary: Participants experiencing deterioration in NYHA class (yes/no) from randomisation (month 0) to end-of-treatment (month 12) (Count of participants), Supportive secondary: Change in KCCQ total symptom score from randomisation (month 0) to end-of-treatment (month 12) (Score, range 0-100), Supportive secondary: Change in KCCQ physical limitations score from baseline (month 0) to end-of-treatment (month 12) (Score, range 0-100), Supportive secondary: Change in KCCQ social limitations score from randomisation (month 0) to end-of-treatment (month 12) (Score, range 0-100), Supportive secondary: Change in KCCQ health-related quality of life score from randomisation (month 0) to end-of-treatment (month 12) (Score, range 0-100)

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