A Study to Learn More About the Change in the Blood Levels of Transthyretin When Participants With Transthyretin Amyloidosis With Cardiomyopathy Switch From Tafamidis to Acoramidis
This study is for people with a heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). This condition happens when a protein called transthyretin (TTR) builds up in the heart, making it hard for the heart to pump blood. Both tafamidis and acoramidis are medicines that help stabilize this protein and stop clumps from forming. Researchers want to see what happens to the levels of this TTR protein in the blood when people switch from taking tafamidis to taking acoramidis. The main goal is to understand if acoramidis might increase these protein levels more than tafamidis does. Participants will take acoramidis for up to six months, with regular check-ups to monitor their health and blood TTR levels.
En un coup d'œil
De quoi parle cette étude ?
Imagine your heart needing a helping hand because a sticky protein, called transthyretin (TTR), has started to build up and make it stiff. This condition is called transthyretin amyloid cardiomyopathy (ATTR-CM). This protein is normally helpful, but sometimes it breaks down and forms harmful clumps that settle in the heart, making it harder to pump blood effectively. This can lead to heart failure symptoms. These protein problems can be due to natural aging or passed down through families.
Medicines like tafamidis and acoramidis are designed to help by attaching to the TTR protein and making it more stable. This helps prevent it from breaking down and forming those troublesome clumps. By doing this, these medicines aim to slow down the disease, improve heart function, and increase the healthy TTR levels in your blood. Acoramidis is already an approved treatment in the UK and other places for people with ATTR-CM, just like tafamidis.
This particular study wants to learn more about what happens when people who are already taking tafamidis switch to acoramidis. The main thing the researchers want to find out is if acoramidis causes your blood TTR levels to go up even more than they did with tafamidis. They believe that higher, more stable TTR levels could be beneficial for people with this condition. Understanding this change could help doctors decide the best way to manage ATTR-CM in the future.
Points clés
- The study explores switching from tafamidis to acoramidis for ATTR-CM.
- It aims to see if acoramidis further increases TTR protein levels in the blood.
- Participants will take acoramidis for up to 6 months.
- There will be regular check-ups at home and in the clinic.
- The total study duration is about 8 months.
- This research helps understand treatment options for ATTR-CM.
Qui peut être éligible ?
To be part of this study, you need to be an adult between 18 and 90 years old. You must have a confirmed diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) and have been taking tafamidis regularly for at least three months before the study starts. Your heart condition should be stable, generally meaning you don't have severe symptoms that limit your daily activities too much. Also, your kidney function needs to be generally good, and certain heart-related blood test levels should be within a specific range.
There are also reasons why you might not be able to join. For example, if you've had a liver or heart transplant, or if one is planned soon. If you have active cancer, very severe kidney problems, or have had recent heart problems like a heart attack, you likely won't be able to participate. Certain other medicines or health conditions that could interfere with the study or your safety would also prevent you from joining. The study doctors will carefully review your full medical history to make sure the study is right for you.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Are you between 18 and 90 years old?
- Do you have a diagnosis of ATTR-CM?
- Have you been taking tafamidis for at least the last 3 months?
- Is your heart condition generally stable (NYHA Class I or II)?
- Do you have suitable kidney function (eGFR 30 or higher)?
- Have you avoided recent major heart problems or surgeries?
En quoi consiste la participation ?
If you join this study, your journey will involve a few steps. First, there will be a screening visit where doctors will check your health and review your medical history to make sure the study is suitable for you. During this screening, you will continue taking your usual tafamidis. You'll have an electrocardiogram (ECG) to check your heart, and your blood pressure and heart rate will be measured. Blood and urine samples will be taken to check your heart, kidney, and thyroid health.
Once you’re approved, you will then switch to taking acoramidis. This means you will take two tablets by mouth twice a day, every day, for up to six months. During this time, there will be a total of nine check-ins. You will visit the study clinic twice: once for the initial screening and once at the very end of the treatment period. A study nurse will visit your home six times during the first month and at three months to check on you and take blood samples. Your final check-in will be a phone call. Throughout the study, doctors will regularly monitor your health for any medical issues. You will know exactly which treatment you are receiving. The total time you'll be involved in the study is about eight months.
Risques et avantages potentiels
Emplacements (10)
- Universitätsklinikum St. Pölten - Lilienfeld - Klinische Abteilung für Innere Medizin 3Code postal vérifiéSankt Pölten, Autriche· Retiré
- Medizinische Universität Wien- Universitätsklinik für Innere Medizin II, Klinische Abteilung für KardiologieCode postal vérifiéVienne, Autriche· Pas encore en recrutement
- Klinik Favoriten - 5.Medizinische Abteilung-KardiologieCode postal vérifiéVienne, Autriche· Pas encore en recrutement
- Klinik Ottakring - 3. Medizinische Abteilung mit Kardiologie, internistischer Intensivmedizin und AmbulanzCode postal vérifiéVienne, Autriche· Pas encore en recrutement
- Medizinische Universität Graz- Klinische Abteilung für KardiologieVille uniquementVienne, Autriche· Recrutement
- Krankenhaus St. Josef Braunau | Innere Medizin ICode postal vérifiéBraunau am Inn, Austria· Pas encore en recrutement
- AZ St-Jan Brugge-Oostende A.V.Code postal vérifiéBruges, Belgique· Pas encore en recrutement
- Hôpital Erasme/Erasmus ZiekenhuisCode postal vérifiéBruxelles, Belgique· Pas encore en recrutement
- KVZ Kardiovaskulaeres Zentrum Darmstadt GmbHCode postal vérifiéDarmstadt, Germany· Pas encore en recrutement
- Oslo Universitetssykehus HF, RikshospitaletCode postal vérifiéOslo, Norway· Pas encore en recrutement
Questions fréquentes
What is ATTR-CM?
ATTR-CM is a heart condition where a protein called transthyretin builds up in the heart, making it stiff and hard to pump blood efficiently.
Quel est l'objectif principal de cette étude ?
The main goal is to see if switching from tafamidis to acoramidis increases levels of the TTR protein in the blood even more than tafamidis does.
Combien de temps vais-je participer à l'étude ?
You could be in the study for about 8 months in total, including screening and treatment periods.
Will I know which medicine I'm getting?
Yes, you will know that you are taking acoramidis during the treatment period of this study.
Whom should I contact if I have questions?
You should speak with your study doctor or nurse if you have any questions about the study.
Comment en savoir plus
Bayer Clinical Trials Contact
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
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