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RecrutamentoFASE3INTERVENCIONISTA

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

This study, called TRITON-CM, is looking at a new treatment called nucresiran for people who have a specific heart condition called transthyretin amyloidosis cardiomyopathy. This condition affects the heart and can lead to heart failure. We want to find out if nucresiran can help patients live longer, reduce serious heart problems, and improve their overall health and quality of life. Participants will either receive the new medicine or a dummy medicine (placebo) through an injection, and their health will be closely monitored. This research is important because it could lead to better treatments for this heart condition.

Em resumo

Status
Recrutamento
Fase
FASE3
Patrocinador
Alnylam Pharmaceuticals
Meta de inscrição
1,750
Iniciar
02 Jul 2025
Conclusão estimada
30 Nov 2032

Sobre o que é este estudo?

You might have heard about a condition called transthyretin amyloidosis, or ATTR amyloidosis for short. This is when a protein in your body, called transthyretin, doesn't fold properly and clumps together. These clumps, called amyloid, can build up in different parts of the body, including the heart. When it affects the heart, it's called transthyretin amyloidosis with cardiomyopathy, and it can make your heart muscle stiff and lead to heart failure.

This study is testing a new medicine called nucresiran. We want to see if this medicine can help people with this heart condition. The main things we're looking to find out are whether nucresiran can help people live longer, reduce the number of serious heart-related health problems they experience, and generally improve how they feel and their day-to-day life, compared to a placebo (a dummy medicine that looks the same but contains no active drug).

If successful, nucresiran could become a new treatment option for people living with transthyretin amyloidosis cardiomyopathy. Clinical trials like this are a very important part of developing new medicines, as they help doctors understand if a treatment is safe and effective before it can be made widely available.

Pontos principais

  • This study is testing a new medicine called nucresiran for a heart condition.
  • It aims to see if nucresiran can improve health and reduce heart problems.
  • You might receive the new medicine or a dummy treatment (placebo).
  • Regular health checks and blood tests will be part of the study.
  • The study lasts several years and involves regular clinic visits.
  • Você pode parar de participar a qualquer momento.

Quem pode ser elegível?

To join this study, you need to have been diagnosed with transthyretin amyloidosis that affects your heart, whether it's the type you're born with (hATTR) or the type that develops later in life (wATTR). You also need to have a history of heart failure, which might mean you've been in hospital for it or you're taking medication to help with symptoms like fluid build-up.

Your blood test results for a specific heart marker (called NT-proBNP) also need to be within a certain range. If you're already taking other approved medicines for your ATTR amyloidosis or for heart failure, that’s generally okay and you might still be able to take part.

However, you can't join if your heart failure is very severe (NYHA Class IV), or if it's quite severe (NYHA Class III) and your ATTR condition is also at an advanced stage (Stage 3). Also, if your nerves are significantly affected by the condition (PND Score IIIa, IIIb, or IV) or if your kidney function is very low, you won't be able to participate. Lastly, if you've previously received or are currently receiving other specific treatments that lower the transthyretin protein, you unfortunately cannot join this study.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Do you have a diagnosis of transthyretin amyloidosis affecting your heart?
  2. Have you had heart failure symptoms or been hospitalised for heart failure?
  3. Is your kidney function generally good (not very low)?
  4. Are your heart failure symptoms not too severe (not Class IV NYHA)?
  5. Have you not received specific TTR-lowering treatments in the past?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part in this study, you will either receive the new medicine (nucresiran) or a placebo (a dummy treatment). Both will be given as injections. You will have regular visits to the clinic where doctors and nurses will monitor your health, perform physical exams, take blood samples, and conduct tests to check your heart and general well-being. They will also ask you to fill out questionnaires about how you are feeling and your quality of life. The total duration of your participation in the study will depend on how long the researchers need to collect enough information to understand the medicine's effects, but it typically involves several years of regular check-ups and follow-up after the main treatment period.

Riscos e benefícios potenciais

Taking part in this study might offer a chance to receive a new medicine that could potentially help manage your heart condition and improve your quality of life, although it's important to remember that it might also be a placebo. As with any medicine, there could be side effects or risks that your study doctor will discuss with you in detail. There will also be appointments, tests, and procedures involved, which might take up some of your time. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (266)

  • Clinical Trial Site
    Código postal verificado
    La Jolla, Estados Unidos· Recrutamento
  • Clinical Trial Site
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    Laguna Hills, United States· Recrutamento
  • Clinical Trial Site
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    Stanford, Estados Unidos· Recrutamento
  • Clinical Trial Site
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    Aurora, Estados Unidos· Recrutamento
  • Clinical Trial Site
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    Norwich, United States· Recrutamento
  • Clinical Trial Site
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    Washington D.C., Estados Unidos· Recrutamento
  • Clinical Trial Site
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    Brandon, United States· Recrutamento
  • Clinical Trial Site
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    Miami, Estados Unidos· Recrutamento
  • Clinical Trial Site
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    Atlanta, Estados Unidos· Recrutamento
  • Clinical Trial Site
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    Gainesville, Estados Unidos· Recrutamento
  • Clinical Trial Site
    Código postal verificado
    Tucker, United States· Recrutamento
  • Clinical Trial Site
    Código postal verificado
    Chicago, Estados Unidos· Recrutamento

Perguntas frequentes

What is transthyretin amyloidosis cardiomyopathy?

It's a heart condition where an abnormal protein builds up in the heart, making it stiff and weaker, which can lead to heart failure.

What is nucresiran?

Nucresiran is a new medicine being tested to see if it can help treat transthyretin amyloidosis cardiomyopathy.

What is a 'placebo' in a study?

A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps doctors compare the new medicine's effects accurately.

Saberei se estou recebendo o medicamento real ou o placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete, for the most accurate results.

Quanto tempo estarei no estudo?

Your participation will involve regular visits over several years to monitor your health and the effect of the treatment.

Como saber mais

Clinical Trial Information Line

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