2023-506988-34-00招募中3 期
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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 318
- 试验地点
- 67
- 主要终点
- 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))
研究概览
简要总结
To demonstrate superiority of ziltivekimab s.c. once-monthly versus placebo, both added to standard of care, on heart failure symptoms and physical function in participants with HFmrEF or HFpEF, and systemic inflammation
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Serum hs-CRP 2 mg/L at screening (visit 1).
- •NT-proBNP ≥ 225 pg/mL (375 pg/mL for patients with atrial fibrillation/flutter) at screening.
- •Diagnosis of heart failure (NYHA Class II-III).
- •LVEF > 40% documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g. MI or HF hospitalisation).
- •Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following: a) LA volume index > 34mL/m2 b) LA diameter ≥ 3.8cm c) LA length ≥ 5.0cm d) LA area ≥ 20cm2 e) LA volume ≥ 55mL f) Intraventricular septal thickness ≥ 1.1cm g) Posterior wall thickness ≥ 1.1cm h) LV mass index ≥ 115g∕m2 in men or ≥ 95 g∕m2 in women i) E/e’ (mean septal and lateral) ≥ 10 j) e’ (mean septal and lateral) < 9cm/s
- •No heart failure hospitalisations or urgent heart failure visits between screening and randomisation.
- •Able to perform the 6MWT at screening with a minimum distance of 100 metres. (NOTE: Patients are not eligible if any disease or condition, rather than HF, constitutes the main reason for limiting the ability to exercise/reduces exercise capacity).
- •KCCQ clinical summary score < 80 at screening
排除标准
- •Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1).
- •Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
- •Systolic blood pressure ≥180 mmHg at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving ≥3 antihypertensive drugs. (NOTE: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
- •Heart rate above 110 or below 40 beats per minute as evaluated on the ECG performed at screening (visit 1). (NOTE: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
- •Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (NOTE: Planned coronary angiogram is not exclusionary).
- •Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1).
- •Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).
- •Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease.
- •Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
- •Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism).
研究组 & 干预措施
Placebo (ziltivekimab C)
Placebo
干预措施: Placebo (ziltivekimab C) (Drug)
ziltivekimab
Test
干预措施: ziltivekimab (Drug)
结局指标
主要结局
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))
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))
次要结局
- 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)
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (67)
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