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.
A colpo d'occhio
Di cosa tratta questo studio?
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.
Punti chiave
- 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.
Chi può essere idoneo?
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.
Questo studio potrebbe fare al caso tuo?
Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.
- Hai tra i 18 e i 90 anni?
- 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?
Cosa comporta la partecipazione?
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.
Rischi e benefici potenziali
Locations (10)
- Universitätsklinikum St. Pölten - Lilienfeld - Klinische Abteilung für Innere Medizin 3Codice postale verificatoSankt Pölten, Austria· Ritirato
- Medizinische Universität Wien- Universitätsklinik für Innere Medizin II, Klinische Abteilung für KardiologieCodice postale verificatoVienna, Austria· Non ancora in fase di reclutamento
- Klinik Favoriten - 5.Medizinische Abteilung-KardiologieCodice postale verificatoVienna, Austria· Non ancora in fase di reclutamento
- Klinik Ottakring - 3. Medizinische Abteilung mit Kardiologie, internistischer Intensivmedizin und AmbulanzCodice postale verificatoVienna, Austria· Non ancora in fase di reclutamento
- Medizinische Universität Graz- Klinische Abteilung für KardiologieSolo cittàVienna, Austria· Reclutamento
- Krankenhaus St. Josef Braunau | Innere Medizin ICodice postale verificatoBraunau am Inn, Austria· Non ancora in fase di reclutamento
- AZ St-Jan Brugge-Oostende A.V.Codice postale verificatoBruges, Belgium· Non ancora in fase di reclutamento
- Hôpital Erasme/Erasmus ZiekenhuisCodice postale verificatoBruxelles, Belgio· Non ancora in fase di reclutamento
- KVZ Kardiovaskulaeres Zentrum Darmstadt GmbHCodice postale verificatoDarmstadt, Germany· Non ancora in fase di reclutamento
- Oslo Universitetssykehus HF, RikshospitaletCodice postale verificatoOslo, Norway· Non ancora in fase di reclutamento
Domande comuni
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.
Qual è l'obiettivo principale di questo studio?
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.
Per quanto tempo sarò nello studio?
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.
Come saperne di più
Bayer Clinical Trials Contact
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