ATHENA: A research study looking into how ziltivekimab works compared to placebo in people with hear

Cardiology
Dawn Lombardo
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
Cardiac Disease
Cardiovascular Disease
Heart - Cardiovascular Circulatory
Heart Failure

Study Description

Eligibility

Is an adult male or female patient 18 years of age

Has evidence in the medical history supporting a diagnosis of clinical HF syndrome, NYHA functional class II to III, with the duration of at least 6 months prior to the time of Screening. The HF syndrome is defined by documentation of 1 or more of the following:

At least 1 of the typical symptoms due to HF such as dyspnea and/or fatigue limiting exercise capacity;

At least 1 of the typical signs of HF such as peripheral edema, elevated jugular venous pressure, pulmonary crackles; or

Hospitalization, emergency department visit, or outpatient visit for HF requiring intravenous (IV) or subcutaneous (SQ) diuresis within the past 12 months.

Has ejection fraction (EF) ≤ 40% by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening;

Has NT-proBNP level ≥ 600 pg/mL at the time of Screening. Patients with atrial fibrillation or flutter at the time of Screening are required to have an NT-proBNP level of ≥ 1000 pg/mL at the time of Screening;

Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgement, for a minimum of 4 weeks prior to the time of Screening and during Screening, with no planned changes after randomization.

Has had no addition of new guideline-directed HF therapy within the 3 months prior to the time of Screening or during the Screening Period;

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