BridgeMD
ATHENA: A research study looking into how ziltivekimab works compared to placebo in people with heart failure and inflammation
EU CTIS ID: 2023-506988-34-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Australia
- India
- Malaysia
- Turkey
- Canada
- Argentina
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Australia; India; Malaysia; Turkey; Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.