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RecruitingPHASE2INTERVENTIONAL

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

This research is investigating a new medicine, Pelacarsen (TQJ230), for people with a condition called aortic stenosis. This is when the main valve in your heart, the aortic valve, becomes stiff and narrow, making it harder for blood to flow out to your body. We are trying to find out if Pelacarsen can slow down this process. Participants will be given monthly injections of either the study medicine or a 'dummy' medicine (placebo). This will help us understand if Pelacarsen is safe and effective in preventing the condition from getting worse. We are particularly interested in people who have higher levels of a specific fat in their blood, called Lipoprotein(a), as this may play a role in aortic stenosis.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Novartis Pharmaceuticals
Enrolment target
502
Start
07 Mar 2024
Estimated completion
12 Mar 2030

What is this study about?

This study is looking into a heart condition called aortic stenosis. This happens when the main valve in your heart, the aortic valve, becomes stiff and narrow over time. This makes it harder for your heart to pump blood out to the rest of your body, which can lead to symptoms like breathlessness or chest pain. For some people, this condition can get worse quite quickly.

Researchers are investigating whether a new medicine, called Pelacarsen (also known as TQJ230), could help slow down the progress of aortic stenosis. There's a particular fat in the blood called Lipoprotein(a) that some scientists believe might contribute to this stiffening and narrowing. Pelacarsen is designed to lower the level of this fat, and this study aims to see if that helps protect the aortic valve.

By taking part, you would be helping doctors understand more about aortic stenosis and if Pelacarsen could be a new way to treat it. This is important because there aren't currently many medicines that can stop this condition from getting worse, and finding one could make a real difference to people's lives.

Key takeaways

  • This study evaluates a new medicine (Pelacarsen) for aortic stenosis.
  • It aims to see if the medicine can slow down the narrowing of the heart valve.
  • Participants will receive monthly injections of the medicine or a placebo.
  • The study focuses on people with higher levels of Lipoprotein(a) in their blood.
  • It's for people with mild or moderate aortic stenosis, aged 50-80.

Who may be eligible?

To join this study, we are looking for men and women between the ages of 50 and 80. You would need to have been diagnosed with either mild or moderate calcific aortic valve stenosis, which is when the aortic valve is becoming stiff and narrowed. We also need to check your blood for a specific fat called Lipoprotein(a) – your levels would need to be above a certain amount for you to take part.

There are also some reasons why you might not be able to join. For example, if your aortic stenosis is already severe, or if you have certain other serious health issues like uncontrolled high blood pressure, severe kidney or liver problems, or a history of certain cancers or bleeding in the brain. They also can't include women who are pregnant or breastfeeding.

All your existing health conditions that might increase your risk of heart problems would need to be well managed before you start the study. There might be some other specific reasons why you couldn't take part, which the study team would explain to you.

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 between 50 and 80 years old?
  2. Have you been diagnosed with mild or moderate aortic stenosis?
  3. Do you have high levels of Lipoprotein(a) in your blood?
  4. Are your existing health conditions well managed?
  5. Are you NOT pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive monthly injections, either of the study medicine Pelacarsen or a placebo (a dummy medicine that looks the same but contains no active drug). You wouldn't know which one you are getting. Throughout the study, you'd have regular check-ups, which would involve blood tests, heart scans (like echocardiograms to look at your aortic valve), and general health assessments. These visits are important so the study team can monitor your health, how the medicine is affecting you, and how your aortic stenosis is progressing. The total duration of your participation in the study would be explained by the research team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from taking part, but your contribution could help doctors learn more about aortic stenosis and potentially help others in the future. As with any new medicine, there's a chance of side effects, which the medical team will discuss with you. You will be closely monitored throughout the study for any health changes. Remember, joining is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (139)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Heart Center Research Llc
    Verified postcode
    Huntsville, United States· Recruiting
  • Cardiovascular Res Found
    Verified postcode
    Beverly Hills, United States· Recruiting
  • National Heart Institute
    Verified postcode
    Beverly Hills, United States· Recruiting
  • Flourish Clinical Resrch Covin
    Verified postcode
    Covina, United States· Recruiting
  • Valley Clinical Trials
    Verified postcode
    Northridge, United States· Recruiting
  • Stanford University Medical Center
    Verified postcode
    Palo Alto, United States· Recruiting
  • University Of California San Diego
    Verified postcode
    San Diego, United States· Recruiting
  • UC San Francisco Medical Center
    Verified postcode
    San Francisco, United States· Recruiting
  • Excel Medical Clinical Trials LLC
    Verified postcode
    Boca Raton, United States· Withdrawn
  • Nova Clinical Research LLC
    Verified postcode
    Bradenton, United States· Recruiting
  • Flourish Res Acq LLC North Miami
    Verified postcode
    Miami, United States· Recruiting
  • Inpatient Research Clinical LLC
    Verified postcode
    Miami Lakes, United States· Recruiting

Common questions

What is Lipoprotein(a)?

It's a type of fat in your blood that some research suggests might be linked to heart conditions like aortic stenosis.

What is a placebo?

A placebo is a 'dummy' medicine; it looks exactly like the study drug but contains no active ingredients. It helps us see if the real medicine is truly effective.

Will I know if I'm getting the real medicine?

No, neither you nor the study team will know if you are getting Pelacarsen or the placebo during the study. This helps make the study as fair as possible.

What is calcific aortic valve stenosis?

It's a condition where the main valve in your heart becomes stiff and narrow over time due to calcium buildup, making it harder for your heart to pump blood.

Is there a cost to participate?

No, all study-related treatments and tests would be provided at no cost to you.

How to find out more

Novartis Pharmaceuticals

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 Multicenter Trial Assessing the Impact of Lipoprotein(a) L…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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