CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis
The CLEOPATTRA study is investigating a new medicine, Coramitug (also known as NNC6019-0001), for people who have heart failure due to a condition called transthyretin amyloid (ATTR) amyloidosis. This condition causes unusual protein deposits to build up in the heart, making it harder for the heart to work properly. The main goal of this study is to find out if Coramitug can help lower the risk of heart-related deaths and other serious heart problems. Participants in the study will be randomly assigned to receive either the new medicine or a placebo (a treatment that looks the same but contains no active medicine). It's important to know that everyone in the study will continue to receive the standard heart treatments their doctor recommends, alongside their study treatment. This is a Phase 3 study, meaning the medicine has already been tested in smaller groups and is now being tested on a larger scale to confirm its effectiveness and safety.
Em resumo
Sobre o que é este estudo?
The CLEOPATTRA study is focusing on a specific type of heart problem called transthyretin amyloid cardiomyopathy, often shortened to ATTR-CM. In this condition, a protein called transthyretin doesn't fold correctly and builds up in the heart. This build-up makes the heart muscle stiff and thick, which means it can't pump blood as effectively as it should. This can lead to symptoms of heart failure, such as breathlessness, tiredness, and swelling.
Researchers want to see if a new medicine, Coramitug, can make a difference for people living with ATTR-CM. The hope is that this medicine might be able to slow down or reduce the damage to the heart, potentially leading to fewer serious heart problems and perhaps even improving how well people live with the condition. By comparing Coramitug to a placebo, doctors can understand if the medicine itself is causing any positive changes, rather than other factors.
This study is important because ATTR-CM is a serious condition, and new treatments are always needed to help people manage it better. The results of this large study will help doctors decide if Coramitug could become a new option for treating ATTR-CM and improving the lives of those affected.
Pontos principais
- The study tests a new medicine, Coramitug, for heart failure caused by ATTR amyloidosis.
- It aims to reduce heart-related deaths and illness.
- Participants will receive either Coramitug or a placebo.
- All participants will continue their usual heart treatments.
- It's a large-scale Phase 3 clinical trial.
Quem pode ser elegível?
To be considered for this study, you need to be at least 18 years old. You must have a confirmed diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM). This diagnosis means doctors have found that your heart has these specific protein deposits, making the walls of your heart thicker and causing heart failure.
Doctors will need to confirm your ATTR-CM diagnosis using specific tests. This could involve a biopsy (taking a small sample of heart tissue), or special scans of your heart, often combined with other blood or tissue tests. These tests help ensure that the heart problem is definitely caused by ATTR amyloid rather than something else.
There are two main types of ATTR-CM – wild-type and variant. The study is open to people with both types. About 15% of the people in the study are expected to have the variant type.
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.
- Você tem 18 anos ou mais?
- Have you been diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM)?
- Have tests shown protein build-up in your heart causing thicker heart walls and heart failure?
- Are you willing to undergo specific heart scans and other diagnostic tests if needed?
O que envolve a participação?
Information about what taking part involves is not fully detailed in the provided summary. However, in most clinical trials like this, you would typically have regular visits to a clinic or hospital. These visits would include check-ups, blood tests, and possibly heart scans to monitor your condition and how the study medicine is affecting you. You would take either the study medicine (Coramitug) or the placebo as instructed, alongside your usual heart medications. The total duration of your participation and how many visits are needed would be explained in detail by the study team before you decide to join.
Riscos e benefícios potenciais
Locations (299)
- Mayo Clinic in ArizonaCódigo postal verificadoPhoenix, Estados Unidos· Recrutamento
- University of California San Diego (UCSD) - Sulpizio Cardiovascular Center (SCVC)Código postal verificadoLa Jolla, Estados Unidos· Recrutamento
- Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)Código postal verificadoLos Angeles, Estados Unidos· Recrutamento
- Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer InstituteCódigo postal verificadoLos Angeles, Estados Unidos· Ainda não recrutando
- UCI Medical CenterCódigo postal verificadoOrange, Estados Unidos· Recrutamento
- Profound Research LLC at Southern California Heart SpecialistsCódigo postal verificadoPasadena, Estados Unidos· Recrutamento
- University of California, San Francisco Medical CenterCódigo postal verificadoSão Francisco, Estados Unidos· Recrutamento
- NorthBay Clinical ResearchCódigo postal verificadoSanta Rosa, Estados Unidos· Recrutamento
- Lucile Packard Children's HospitalCódigo postal verificadoStanford, Estados Unidos· Recrutamento
- Yale University School of MedicineCódigo postal verificadoNew Haven, Estados Unidos· Recrutamento
- MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital CenterCódigo postal verificadoWashington D.C., Estados Unidos· Recrutamento
- UF Health Heart and Vascular HospitalCódigo postal verificadoGainesville, Estados Unidos· Recrutamento
Perguntas frequentes
What is ATTR amyloidosis?
It's a condition where an unusual protein called transthyretin builds up in your heart, making it harder for your heart to work well.
What is Coramitug?
Coramitug is the name of the new medicine being tested in this study to see if it can help people with heart failure due to ATTR amyloidosis.
O que é um placebo?
A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare the real medicine's effects.
Will I still take my regular heart medicines?
Yes, everyone in the study will continue to receive their usual heart treatments as recommended by their doctor.
What happens if I want to leave the study?
You are free to leave the study at any time, for any reason, and your decision will not affect your future medical care.
Como saber mais
Novo Nordisk
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