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Monoclonal Antibodies

Ziltivekimab for Heart Failure (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomisation (month 0) to end-of-treatment (month 12)

Awards & highlights

ATHENA 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.Check my eligibility

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.See study design

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.

ATHENA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

ATHENA Trial 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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation (month 0) to end-of-treatment (month 12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)

Secondary outcome measures

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 more

ATHENA 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,516 Previous Clinical Trials

2,414,882 Total Patients Enrolled

8 Trials studying Heart Failure

29,363 Patients Enrolled for Heart Failure

Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S

36 Previous Clinical Trials

522,374 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being enrolled in this ongoing clinical trial?

"As per the information available on clinicaltrials.gov, this particular study is not actively seeking participants at present. Its initial posting was made on April 1st, 2024, and it was last updated on December 28th, 2023. However, it's important to note that there are currently 1054 other ongoing studies that are actively enrolling participants."

Answered by AI

Has Ziltivekimab received official approval from the FDA?

"Given that this is a Phase 3 trial, implying the existence of data supporting both efficacy and safety from multiple rounds, our team at Power rates Ziltivekimab's safety as a 3."

Answered by AI

Are there numerous facilities conducting this clinical trial within the borders of the United States?

"Presently, there are 95 clinical trial sites actively recruiting patients for this study. These locations include Belagavi, Ipoh, West Sussex, and numerous others. It is recommended that individuals considering enrollment choose the clinic closest to them in order to minimize travel requirements."

Answered by AI