What side effects are associated with this type of intervention?

Common treatments for heart failure include medications such as ACE inhibitors, beta-blockers, diuretics, and anti-inflammatory agents like Ziltivekimab. Ziltivekimab, an anti-inflammatory agent targeting IL-6, is being studied for its potential benefits in heart failure with inflammation. Known side effects of similar anti-inflammatory treatments can include injection site reactions, increased risk of infections, and potential allergic reactions. Other heart failure treatments may cause side effects such as hypotension, electrolyte imbalances, renal dysfunction, and fatigue. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

FDA-approved treatments for heart failure primarily include medications such as ACE inhibitors, beta-blockers, diuretics, and mineralocorticoid receptor antagonists. While Ziltivekimab is an anti-inflammatory agent targeting IL-6, similar biologic treatments for heart failure are not commonly highlighted in FDA approvals. However, anti-inflammatory strategies are being explored in clinical trials, reflecting a growing interest in targeting inflammation as a therapeutic approach for heart failure.

What other types of research exist?

Promising novel alternatives to Ziltivekimab for heart failure patients include Canakinumab (an IL-1β inhibitor), Anakinra (an IL-1 receptor antagonist), and Tocilizumab (an IL-6 receptor antagonist). These agents target inflammatory pathways and have shown potential in reducing inflammation associated with heart failure.

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Ziltivekimab for Heart Failure (HERMES 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 [classification] [NYHA] Class II-IV).

Hospitalisation or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg/mL.

Must not have

Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1).

Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation, within 30 days prior to screening (visit 1).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomisation (month 0) to end of study (up to 48 months)

Awards & highlights

Pivotal Trial

Summary

This trial is testing ziltivekimab to see if it can help people with heart failure and inflammation by reducing inflammation and improving heart function.

Who is the study for?

This trial is for people with heart failure and inflammation. They must have a certain level of left atrial volume, high levels of C-reactive protein, and meet specific criteria related to heart function documented by echocardiography or hospital visits. It's not for those who've had recent major cardiac events/surgery, planned procedures, specific cardiomyopathies, extremely high blood pressure or abnormal heart rates.

What is being tested?

The study tests if Ziltivekimab can treat heart failure with inflammation compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo and monitored up to 4 years through clinic visits and an app that tracks injections and questionnaires.

What are the potential side effects?

While the potential side effects are not listed here, common ones associated with medications like Ziltivekimab may include injection site reactions, nausea, headaches, possible increased risk of infections due to immune system alteration.

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 heart failure and it affects my daily activities.

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I was hospitalized for heart failure and needed IV treatment in the last 9 months, and my NT-proBNP levels are high.

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My heart pumps well, with an LVEF over 40% in the last year.

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My hs-CRP level is 2 mg/L or higher, indicating inflammation related to heart disease.

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I have been diagnosed with heart failure and it affects my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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 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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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 study (up to 48 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomisation (month 0) to end of study (up to 48 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation (month 0) to end of study (up to 48 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF Visit

Secondary study objectives

Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)

Change in Estimated Glomerular Filtration Rate (eGFR) (Chronic Kidney Disease - Epidemiology Collaboration [CKD-EPI])

Change in High-sensitivity C-reactive Protein (hs-CRP)

+15 more

Side effects data

From 2020 Phase 2 trial • 264 Patients • NCT03926117

Oedema peripheral

Diarrhoea

Dizziness

Nasopharyngitis

Urinary tract infection

Cough

Hypotension

Arthralgia

Prostate cancer

Bradycardia

Cardiac failure congestive

Acute kidney injury

Ankle fracture

Lumbar vertebral fracture

Cellulitis staphylococcal

Intestinal ischaemia

Septic shock

100%

80%

60%

40%

20%

Study treatment Arm

Ziltivekimab 30 mg

Placebo

Ziltivekimab 7.5 mg

Ziltivekimab 15 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ZiltivekimabExperimental Treatment1 Intervention

Participants will receive ziltivekimab subcutaneous (s.c.) injection once-monthly and added standard of care for up to 4 years.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive ziltivekimab placebo s.c. injection once-monthly and added standard of care for up to 4 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ziltivekimab

2019

Completed Phase 2

~300

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include beta-blockers, ACE inhibitors, diuretics, and anti-inflammatory agents like Ziltivekimab. Beta-blockers work by reducing the heart rate and the force of contraction, which decreases the heart's oxygen demand. ACE inhibitors help relax blood vessels and reduce blood pressure, making it easier for the heart to pump blood. Diuretics remove excess fluid from the body, reducing the workload on the heart. Ziltivekimab, an anti-inflammatory agent targeting IL-6, aims to reduce inflammation, which is a key factor in the progression of heart failure. These treatments are crucial as they address different aspects of heart failure, improving symptoms, and potentially slowing disease progression.

How can we cure a heart "in flame"? A translational view on inflammation in heart failure.