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RecruitingPHASE3INTERVENTIONAL

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

This research study is investigating a new medication called ziltivekimab for people who have both heart failure and inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo (a dummy medicine with no active ingredients). These injections can be given using a pre-filled syringe or a pen-injector. The study aims to understand how ziltivekimab works and if it can improve the health of those with heart failure. The entire study is expected to last for up to four years, and participants will have around 20 clinic visits during that time. They will also use a smartphone app to help track their medication and answer questions about their health.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Novo Nordisk A/S
Enrolment target
5,600
Start
08 May 2023
Estimated completion
02 Jul 2027

What is this study about?

This study is looking into a new medicine called ziltivekimab. It's designed for people who have a condition known as heart failure, especially when they also have signs of inflammation in their body. Heart failure means your heart isn't pumping blood as well as it should, which can cause symptoms like breathlessness and tiredness.

Inflammation is a natural process in the body, but sometimes it can contribute to health problems, including heart conditions. Researchers want to find out if ziltivekimab, by targeting this inflammation, can help improve the health and well-being of people living with heart failure.

The study aims to compare ziltivekimab with a 'placebo', which looks exactly like the study medicine but doesn't contain any active ingredients. This comparison helps scientists determine if any positive effects are truly due to ziltivekimab and not just other factors. Finding new ways to manage heart failure and its related inflammation is very important for improving care.

Key takeaways

  • This study is testing a new medicine called ziltivekimab for heart failure and inflammation.
  • Participants will get monthly injections of either ziltivekimab or a dummy medicine (placebo).
  • The study involves up to 4 years of participation and about 20 clinic visits.
  • A smartphone app will be used to track medication and health information.
  • Eligible participants must have heart failure and signs of inflammation.
  • You can stop participating at any time without affecting your normal care.

Who may be eligible?

To join this study, your doctor will need to check some things. You must be at least 18 years old. You'll need to have a diagnosis of heart failure, and doctors will look at your heart's pumping ability (called 'ejection fraction') to make sure it's over a certain level. They'll also check for signs of inflammation in your blood and look at specific measurements related to your heart's structure.

Your recent health history is also important. For example, doctors will check if you've had a recent hospital stay or urgent visit for worsening heart failure. They will use blood tests to measure certain substances that indicate heart strain or inflammation.

These checks are important to make sure the study includes people who could benefit most from the treatment being tested and that the results are as clear as possible. Everyone who takes part needs to fit specific health requirements, which your study doctor will explain in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of heart failure?
  3. Has your doctor told you that you have signs of inflammation (like a higher hs-CRP blood test)?
  4. Has your heart's pumping ability (ejection fraction) been measured as over 40% recently?
  5. Have you recently had a hospital stay or urgent visit because your heart failure got worse?
  6. Are you able to use a smartphone app for tracking your health?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's a commitment that could last up to four years. You would need to attend about 20 clinic visits during this time. At these visits, doctors and nurses will carry out various health checks and tests. You would receive the study medicine, either ziltivekimab or a placebo, as a monthly injection.

You'll be taught how to give yourself these injections either using a pre-filled syringe (which you'd inject into a skinfold) or a pen-injector (which goes into flatter skin). You'll also be asked to use a special app on your smartphone to regularly record when you've taken your injections and to answer questions about how you're feeling and your general health. This helps the study team keep track of your progress and monitor the effects of the treatment.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be that ziltivekimab might improve your heart failure and inflammation, though this is not guaranteed as it's a new medicine being tested. You will also receive close medical attention and monitoring throughout the study. Potential risks could include side effects from the study medicine, or discomfort from injections or clinic visits. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1117)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Advanced Cardiovascular, LLC
    Verified postcode
    Alexander City, United States· Recruiting
  • Eastern Shore Rsrch Inst, LLC
    Verified postcode
    Fairhope, United States· Recruiting
  • Heart Center Rsrch_Hunstville
    Verified postcode
    Huntsville, United States· Recruiting
  • Banner University Medical Ctr
    Verified postcode
    Phoenix, United States· Completed
  • Banner University Medical Ctr
    Verified postcode
    Phoenix, United States· Not yet recruiting
  • Cardiology & Medicine Clinic
    Verified postcode
    Little Rock, United States· Completed
  • InvivoCure -2
    Verified postcode
    Alhambra, United States· Recruiting
  • National Heart Institute Cal
    Verified postcode
    Beverly Hills, United States· Recruiting
  • Valley Clinical Trials
    Verified postcode
    Covina, United States· Recruiting
  • Scripps Memorial Hospital La Jolla
    Verified postcode
    La Jolla, United States· Completed
  • Purushotham & Akther Kotha MD, inc.
    Verified postcode
    La Mesa, United States· Recruiting
  • VA Loma Linda Hlthcr Sys
    Verified postcode
    Loma Linda, United States· Recruiting

Common questions

What is ziltivekimab?

Ziltivekimab is a new medicine being studied to see if it can help people with heart failure and inflammation. It's given as a monthly injection.

What is a placebo?

A placebo is a dummy medicine that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine.

How long does the study last?

The study is expected to last for up to four years in total.

How often will I need to visit the clinic?

You will have around 20 clinic visits throughout the entire study period.

Do I have to use a smartphone app?

Yes, you'll need to use a special smartphone app to record your injections and answer health questionnaires.

How to find out more

Novo Nordisk

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Research Study to Look at How Ziltivekimab Works Compared …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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