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RecruitingOBSERVATIONAL

Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis

The MaesTTRo study is a worldwide study for people with a condition called transthyretin amyloidosis (ATTR). It’s not testing a new treatment, but rather observing how patients live with ATTR and how their current treatments are working over several years. This includes conditions like ATTR affecting the heart (ATTR-CM) or nerves (ATTRv-PN). The study will collect information from patients during their regular clinic visits about their health and the effects of their treatments. This helps doctors better understand the disease and improve care in the future. Data will be collected securely, with patient privacy as a top priority.

At a glance

Status
Recruiting
Sponsor
AstraZeneca
Enrolment target
1,850
Start
25 Jun 2024
Estimated completion
29 Dec 2031

What is this study about?

Imagine a condition where certain proteins build up in your body, affecting parts like your heart or nerves. This is what happens in transthyretin amyloidosis (ATTR). The MaesTTRo study is an important non-interventional study, which means it’s not testing a new drug or procedure. Instead, it’s like watching a long-running movie about people with ATTR from all over the world.

The main goal is to understand how ATTR naturally progresses over time and how different treatments are being used in regular care. Researchers want to see what really happens in daily life for people with this condition and how well existing treatments, including newer ones like eplontersen, are actually working. This information is incredibly valuable because it helps doctors and researchers improve care for future patients.

By gathering information from many patients, the study will provide a clearer picture of ATTR and its treatments. It helps us learn more about symptoms, how the disease changes, and the true impact of different treatments in a real-world setting, rather than in a highly controlled trial. This knowledge can lead to better ways to manage the condition and support people living with ATTR.

Key takeaways

  • It's an observational study, not testing new drugs.
  • Aims to understand ATTR and real-world treatment use.
  • No extra clinic visits or procedures are needed.
  • You'll complete questionnaires during routine appointments.
  • Participation lasts 3 to 7 years.
  • Your contribution helps future understanding of ATTR.

Who may be eligible?

To take part in the MaesTTRo study, you would need to be at least 18 years old and have a confirmed diagnosis of transthyretin amyloidosis (ATTR). It's also important that you are willing and able to understand and sign a consent form, and fill out some health questionnaires on a regular basis.

There are some reasons why you wouldn't be able to join. For example, if you are currently taking part in another clinical trial that is testing a new treatment for ATTR. Also, if you have other types of amyloidosis, like AL or AA amyloidosis, or if you have ATTR but do not have any symptoms yet, you wouldn't be eligible for this particular study.

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 18 years old or older?
  2. Do you have a confirmed diagnosis of ATTR amyloidosis?
  3. Are you willing to complete online health questionnaires?
  4. Are you NOT currently in another ATTR treatment trial?
  5. Do you NOT have AL or AA amyloidosis?
  6. Do you have ATTR symptoms?
Answer every question to see your result.

What does participation involve?

If you decide to join the MaesTTRo study, you won't need any extra clinic visits or procedures. All the information will be collected during your usual appointments with your doctor. You'll be asked to fill out some electronic health questionnaires about your well-being when you first join and then every six months during your routine clinic visits. These questionnaires help researchers understand how you're feeling and how your condition affects you.

The study will also gather information about your health and treatments from your medical records, just as your doctor usually collects it. There are no new medications to take as part of this study. The total time you'd be involved in the study could range from at least three years, up to seven years, depending on when you join.

Potential risks and benefits

A potential benefit of taking part in this study is contributing valuable information that can help doctors and researchers better understand ATTR and its treatments for current and future patients. Because this is an observational study, there are no new medical risks from treatments or procedures unique to the study. The main involvement is providing information and completing questionnaires. You will not receive personal medical advice or treatment from this study. You are free to withdraw from the study at any time without affecting your medical care.

Locations (67)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    La Jolla, United States· Recruiting
  • Research Site
    Verified postcode
    Los Angeles, United States· Recruiting
  • Research Site
    Verified postcode
    San Francisco, United States· Recruiting
  • Research Site
    Verified postcode
    San Francisco, United States· Recruiting
  • Research Site
    Verified postcode
    New Haven, United States· Recruiting
  • Research Site
    Verified postcode
    Washington D.C., United States· Recruiting
  • Research Site
    Verified postcode
    Chicago, United States· Recruiting
  • Research Site
    Verified postcode
    Indianapolis, United States· Recruiting
  • Research Site
    Verified postcode
    Boston, United States· Recruiting
  • Research Site
    Verified postcode
    Boston, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Boston, United States· Recruiting
  • Research Site
    Verified postcode
    Rochester, United States· Recruiting

Common questions

What is the main purpose of the MaesTTRo study?

It's observing people with ATTR over time to understand the condition and how real-world treatments are working.

Do I need to take new medication for this study?

No, this study doesn't involve any new medications. It observes the treatments you are already receiving.

How long will I be in the study?

You'll be followed for at least three years, and potentially up to seven years depending on when you join.

Will I have extra doctor's appointments?

No, all study information will be collected during your regular, routine clinic visits.

How will my personal information be kept safe?

Your privacy is important. In some regions like the US, personal details might be replaced with secure codes, and only anonymous information will be used for analysis.

How to find out more

AstraZeneca Clinical Study Information Center

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 "Non-interventional Study of Patients With Transthyretin (ATT…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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