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Monoclonal Antibodies
Ziltivekimab for Heart Failure and Inflammation (ATHENA Trial)
Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
No heart failure hospitalisations or urgent heart failure visits between screening and randomisation
Must not have
Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomisation (month 0) to end-of-treatment (month 12)
Awards & highlights
Pivotal Trial
Summary
This trial is being done to see if a medicine called ziltivekimab can help treat people with heart failure and inflammation. Participants will either receive the real medicine or a fake medicine (placebo
Who is the study for?
This trial is for individuals with heart failure and inflammation. Participants should not have any other conditions that could interfere with the study or pose a risk to their health.
What is being tested?
The study tests Ziltivekimab, an experimental medication, against a placebo in treating heart failure and inflammation. Patients are randomly assigned to receive either the real drug or placebo, with equal chances of receiving either.
What are the potential side effects?
Since Ziltivekimab is new and not yet approved, potential side effects are unknown but may include reactions at the injection site, fatigue, nausea, or other immune-related responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with moderate to moderately severe heart failure.
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I haven't been hospitalized or needed urgent care for heart failure recently.
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I can walk at least 100 meters in 6 minutes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had a heart attack, stroke, severe chest pain, mini-stroke, or been hospitalized for heart failure in the last 30 days.
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I am scheduled for a heart device placement or a procedure to correct heart rhythm issues.
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My blood pressure is high, above 180 mmHg, or between 160-179 mmHg and I'm on 3 or more blood pressure medications.
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I am scheduled for a procedure to improve blood flow to my heart or other areas during the screening period.
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I have not had major surgery in the last 60 days and do not plan any soon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomisation (month 0) to end-of-treatment (month 12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomisation (month 0) to end-of-treatment (month 12)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
Secondary study objectives
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP)
Change in eGFR (CKD-EPI)
Change in high-sensitivity C-reactive protein (hs-CRP)
+7 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ZiltivekimabActive Control1 Intervention
Participants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months.
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,560 Previous Clinical Trials
3,645,827 Total Patients Enrolled
9 Trials studying Heart Failure
29,426 Patients Enrolled for Heart Failure
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
40 Previous Clinical Trials
525,055 Total Patients Enrolled