A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation (HERMES)

STUDY OVERVIEW

This study sponsored by Novo Nordisk A/S aims to evaluate the efficacy of ziltivekimab in treating individuals with heart failure and inflammation, comparing it to a placebo. Participants will receive study medication through once-monthly injections via pre-filled syringe or pen-injector. Expected to span up to 4 years, the study will involve up to 20 clinic visits, with participants using a study app to record injection details and complete questionnaires.

STUDY GOALS

The goal of this study is to determine the effectiveness of ziltivekimab as a treatment for individuals with heart failure and inflammation, comparing its efficacy against a placebo over a period of up to 4 years, while monitoring participants' adherence and responses through once-monthly injections and the use of a study app.

LOCATION

El Paso, Texas: Dr. David Turbay, MD

INCLUSION CRITERIA

  • Serum high-sensitivity C-reactive protein (hs-CRP) ≥ 2 mg/L at screening.

  • At least one of the following:

    • N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥ 300 pg/mL (or ≥ 600 pg/mL if ongoing atrial fibrillation/flutter) or history of hospitalization for decompensated heart failure with NT-proBNP ≥ 200 pg/mL (or ≥ 600 pg/mL if ongoing atrial fibrillation/flutter) within the last 9 months.

  • Diagnosis of heart failure (NYHA Class II-IV).

  • Left ventricular ejection fraction (LVEF) > 40% documented within 12 months prior to screening.

  • Structural or functional heart disease documented by echocardiography within 12 months prior to screening, meeting specified criteria.

  • No heart failure hospitalizations or urgent heart failure visits between screening and randomization.

exclusion criteria

  • Recent major cardiovascular events or hospitalizations.

  • Systolic blood pressure ≥ 180 mmHg (or 160-179 mmHg with inadequate antihypertensive therapy).

  • Heart rate > 110 or < 40 beats per minute at screening.

  • Planned revascularization or cardiac device procedures.

  • Recent major surgeries or specific cardiomyopathies.

  • Pulmonary hypertension, severe pulmonary disease, or other conditions mimicking heart failure symptoms.

  • Active infection or immunosuppression.

For more information, visit ClinicalTrials.gov.